title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

acronym: ODYSSEY FH I

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
To evaluate the effects of alirocumab on other lipid parameters
To evaluate the safety and tolerability of alirocumab

ReferenceCitation: Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.

ReferenceCitation: Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Ginsberg

full_name: Henry N. Ginsberg

given: Henry N.

family: Langslet

full_name: Gisle Langslet

given: Gisle

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

family: Ceska

full_name: Richard Ceska

given: Richard

family: Dufour

full_name: Robert Dufour

given: Robert

family: Blom

full_name: Dirk Blom

given: Dirk

family: Civeira

full_name: Fernando Civeira

given: Fernando

family: Krempf

full_name: Michel Krempf

given: Michel

family: Lorenzato

full_name: Christelle Lorenzato

given: Christelle

family: Zhao

full_name: Jian Zhao

given: Jian

family: Pordy

full_name: Robert Pordy

family: Baccara-Dinet

full_name: Marie T. Baccara-Dinet

given: Marie T.

family: Gipe

full_name: Daniel A. Gipe

given: Daniel A.

family: Geiger

full_name: Mary Jane Geiger

given: Mary Jane

family: Farnier

full_name: Michel Farnier

journal_name: European Heart Journal

evidence: open (via page says license)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: University of Zaragoza Repository - Zaguan

title: Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

ReferenceCitation: Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan - Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

location_country:
Austria
South Africa
Sweden
United Kingdom
Netherlands
France
Israel
Norway
Russian Federation
Spain
Denmark
United States
Czech Republic
Canada

location_facility:
Investigational Site Number 840455
Investigational Site Number 724405
Investigational Site Number 840424
Investigational Site Number 250401
Investigational Site Number 528412
Investigational Site Number 840425
Investigational Site Number 710408
Investigational Site Number 724406
Investigational Site Number 124407
Investigational Site Number 040403
Investigational Site Number 528416
Investigational Site Number 826409
Investigational Site Number 643410
Investigational Site Number 840426
Investigational Site Number 840406
Investigational Site Number 643407
Investigational Site Number 208401
Investigational Site Number 840415
Investigational Site Number 040402
Investigational Site Number 840407
Investigational Site Number 840461
Investigational Site Number 578401
Investigational Site Number 040405
Investigational Site Number 203401
Investigational Site Number 250403
Investigational Site Number 710405
Investigational Site Number 752404
Investigational Site Number 724403
Investigational Site Number 376402
Investigational Site Number 710402
Investigational Site Number 724404
Investigational Site Number 724407
Investigational Site Number 710401
Investigational Site Number 208403
Investigational Site Number 376401
Investigational Site Number 376405
Investigational Site Number 724408
Investigational Site Number 124406
Investigational Site Number 643406
Investigational Site Number 528408
Investigational Site Number 840452
Investigational Site Number 528411
Investigational Site Number 250402
Investigational Site Number 840417
Investigational Site Number 643402
Investigational Site Number 840430
Investigational Site Number 710409
Investigational Site Number 826408
Investigational Site Number 528406
Investigational Site Number 840411
Investigational Site Number 724409
Investigational Site Number 840408
Investigational Site Number 840422
Investigational Site Number 752401
Investigational Site Number 840418
Investigational Site Number 643412
Investigational Site Number 826403
Investigational Site Number 528402
Investigational Site Number 203403
Investigational Site Number 840428
Investigational Site Number 840412
Investigational Site Number 643413
Investigational Site Number 124401
Investigational Site Number 203402
Investigational Site Number 528409
Investigational Site Number 124404
Investigational Site Number 826405
Investigational Site Number 124403
Investigational Site Number 376404
Investigational Site Number 724402
Investigational Site Number 840460
Investigational Site Number 840456
Investigational Site Number 710404
Investigational Site Number 710403
Investigational Site Number 840421
Investigational Site Number 840419
Investigational Site Number 643408
Investigational Site Number 528410
Investigational Site Number 840404
Investigational Site Number 643401
Investigational Site Number 840429
Investigational Site Number 840401
Investigational Site Number 710406
Investigational Site Number 643409
Investigational Site Number 840409
Investigational Site Number 643404
Investigational Site Number 203405
Investigational Site Number 710407
Investigational Site Number 840410
Investigational Site Number 826402
Investigational Site Number 724401


title: A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation

acronym: KONNECTION

summary: The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United States
Belgium
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes

summary: The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

ReferenceType: result

ReferenceCitation: Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baqué B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.

family: Wissel

full_name: Jörg Wissel

given: Jörg

sequence: first

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

sequence: additional

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

family: Molteni

full_name: Franco Molteni

given: Franco

family: Satkunam

full_name: Lalith Satkunam

given: Lalith

family: Moraleda

full_name: Susana Moraleda

given: Susana

family: Rekand

full_name: Tiina Rekand

given: Tiina

family: McGuire

full_name: John McGuire

given: John

family: Scheschonka

full_name: Astrid Scheschonka

given: Astrid

family: Flatau-Baqué

full_name: Birgit Flatau-Baqué

given: Birgit

family: Simon

full_name: Olivier Simon

given: Olivier

family: Rochford

full_name: Edward T.J. Rochford

given: Edward T.J.

family: Dressler

full_name: Dirk Dressler

family: Simpson

full_name: David M. Simpson

given: David M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurology

oa_colors: green hybrid

oa_host_type: publisher;repository

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceType: derived

ReferenceCitation: Fheodoroff K, Scheschonka A, Wissel J. Goal analysis in patients with limb spasticity treated with incobotulinumtoxinA in the TOWER study. Disabil Rehabil. 2020 Aug 17:1-7. doi: 10.1080/09638288.2020.1804627. [Epub ahead of print]

name: Department of Neurorehabilitation, Gailtal-Klinik Hermagor, Hermagor, Austria

family: Fheodoroff

full_name: Klemens Fheodoroff

given: Klemens

name: Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany

name: Department of Neurology & Neurorehabilitation and Physical Therapy, Vivantes Hospital Spandau, Berlin, Germany

ReferenceCitation: Fheodoroff K, Rekand T, Medeiros L, Koßmehl P, Wissel J, Bensmail D, Scheschonka A, Flatau-Baqué B, Simon O, Dressler D, Simpson DM. Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA. Health Qual Life Outcomes. 2020 Mar 4;18(1):51. doi: 10.1186/s12955-020-01304-4.

repository_institution: Hospital Center of Central Lisbon - Repository of the Hospital Center of Central Lisbon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
repositorio.chlc.min-saude.pt

location_country:
Italy
United States
Spain
France
Norway
Portugal
Germany
Canada

location_facility:
Merz Investigational Site # 033050
Merz Investigational Site # 351003
Merz Investigational Site #033049
Merz Investigational Site # 001235
Merz Investigational Site #039016
Merz Investigational Site # 001197
Merz Investigational Site #047001
Merz Investigational Site #049191
Merz Investigational site #001195
Merz Investigational Site # 039010
Merz Investigational Site #039013
Merz Investigational Site #049300
Merz Investigational Site # 351001
Merz Investigational Site # 033018
Merz Investigational Site #001238
Merz Investigational Site # 001191
Merz Investigational Site # 039015
Merz Investigational Site # 001203
Merz Investigational Site #049022
Merz Investigational Site # 039005
Merz Investigational Site # 039017
Merz Investigational Site # 001232
Merz Investigational Site #049295
Merz Investigational Site #049298
Merz Investigational Site #034022
Merz Investigational Site #049297
Merz Investigational Site #034025
Merz Investigational Site #034007
Merz Investigational Site # 049153
Merz Investigational Site #049296
Merz Investigational Site #001237
Merz Investigational Site #039014
Merz Investigational Site #034024


ReferenceType: background

ReferenceCitation: Piha-Paul SA, Hann CL, French CA, Cousin S, Braña I, Cassier PA, Moreno V, de Bono JS, Harward SD, Ferron-Brady G, Barbash O, Wyce A, Wu Y, Horner T, Annan M, Parr NJ, Prinjha RK, Carpenter CL, Hilton J, Hong DS, Haas NB, Markowski MC, Dhar A, O'Dwyer PJ, Shapiro GI. Phase 1 Study of Molibresib (GSK525762), a Bromodomain and Extra-Terminal Domain Protein Inhibitor, in NUT Carcinoma and Other Solid Tumors. JNCI Cancer Spectr. 2019 Nov 6;4(2):pkz093. doi: 10.1093/jncics/pkz093. eCollection 2020 Apr.

ReferenceCitation: Krishnatry AS, Voelkner A, Dhar A, Prohn M, Ferron-Brady G. Population pharmacokinetic modeling of molibresib and its active metabolites in patients with solid tumors: A semimechanistic autoinduction model. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):709-722. doi: 10.1002/psp4.12639. Epub 2021 Jun 4.

name: Clinical Pharmacology Modelling and Simulation GlaxoSmithKline, Collegeville PA USA

family: Krishnatry

full_name: Anu Shilpa Krishnatry

given: Anu Shilpa

family: Voelkner

full_name: Alexander Voelkner

given: Alexander

name: Epigenetics Research Unit GlaxoSmithKline Collegeville PA USA

family: Dhar

full_name: Arindam Dhar

given: Arindam

family: Prohn

full_name: Marita Prohn

given: Marita

family: Ferron‐Brady

full_name: Geraldine Ferron‐Brady

given: Geraldine

bso_classification: Chemistry

currency_apc_doaj: USD

journal_name: CPT: Pharmacometrics & Systems Pharmacology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nd

license_normalized: cc-by-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Parikh SA, French CA, Costello BA, Marks RS, Dronca RS, Nerby CL, Roden AC, Peddareddigari VG, Hilton J, Shapiro GI, Molina JR. NUT midline carcinoma: an aggressive intrathoracic neoplasm. J Thorac Oncol. 2013 Oct;8(10):1335-8. doi: 10.1097/JTO.0b013e3182a00f41.

family: Parikh

full_name: Sameer A. Parikh

given: Sameer A.

family: French

full_name: Christopher A. French

given: Christopher A.

family: Costello

full_name: Brian A. Costello

given: Brian A.

family: Marks

full_name: Randolph S. Marks

given: Randolph S.

family: Dronca

full_name: Roxana S. Dronca

given: Roxana S.

family: Nerby

full_name: Craig L. Nerby

given: Craig L.

family: Roden

full_name: Anja C. Roden

given: Anja C.

family: Peddareddigari

full_name: Vijay G. Peddareddigari

given: Vijay G.

family: Hilton

full_name: John Hilton

family: Shapiro

full_name: Geoffrey I. Shapiro

given: Geoffrey I.

family: Molina

full_name: Julian R. Molina

given: Julian R.

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

title: NUT Midline Carcinoma: An Aggressive Intrathoracic Neoplasm

location_country:
Netherlands
France
Australia
Spain
United States
United Kingdom
Korea, Republic of

title: A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers

summary: This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of 2 doses of GSK525762 administered as besylate tablet.


design_allocation: Non-Randomized

study_start_date_type: Actual

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com.

lead_sponsor: Sanofi

location_country:
United States
Belgium
France
Spain

location_facility:
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 840005
Investigational Site Number 840009
Investigational Site Number 840021
Investigational Site Number 840004
Investigational Site Number 840020
Investigational Site Number 840015
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 250003
Investigational Site Number 840017
Investigational Site Number 840008
Investigational Site Number 840104
Investigational Site Number 840006
Investigational Site Number 840002
Investigational Site Number 840018
Investigational Site Number 840010
Investigational Site Number 056001
Investigational Site Number 840022
Investigational Site Number 840007

ipd_sharing: Yes

type: Other Identifier

source: euctr

title: International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

summary:
Primary Objective:

The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.


title: A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy

summary: This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

lead_sponsor: Genentech, Inc.

location_country:
Italy
Germany
France
Bulgaria
Romania
Hungary
Belgium
Australia
Spain
United States
United Kingdom


status: Recruiting

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

enrollment_type: Anticipated

location_country:
Italy
Brazil
South Africa
Lebanon
Netherlands
France
Panama
Greece
Ireland
Spain
Turkey
United States
United Kingdom

acronym: STEADFAST

location_facility: University of Illinois Hospital and Health Sciences System

location_facility: University of Texas Health Science Center at Houston

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: East Carolina University BrodySchool of Med. (3)

location_facility: University of Pennsylvania Medical Center Onc Dept

study_completion_date_type: Anticipated

title: A Phase II, Multicenter, Randomized, Open Label Two Arm Study Comparing the Effect of Crizanlizumab + Standard of Care to Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy

summary: The goal of the study is to compare the efficacy and safety of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

status_simplified: Ongoing


ReferenceCitation: Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6.

ReferenceCitation: Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF. Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial. Arthritis Rheumatol. 2019 Jul;71(7):1174-1184. doi: 10.1002/art.40874. Epub 2019 May 25.

family: Saag

full_name: Kenneth G. Saag

given: Kenneth G.

family: Pannacciulli

full_name: Nicola Pannacciulli

given: Nicola

name: Maastricht University Maastricht The Netherlands

family: Geusens

full_name: Piet Geusens

given: Piet

name: McMaster University Hamilton Ontario Canada

family: Adachi

full_name: Jonathan D. Adachi

given: Jonathan D.

name: Cosme Argerich Hospital Buenos Aires Argentina

family: Messina

full_name: Osvaldo D. Messina

given: Osvaldo D.

family: Morales‐Torres

full_name: Jorge Morales‐Torres

given: Jorge

name: Emkey Arthritis & Osteoporosis Clinic Wyomissing Pennsylvania

family: Emkey

full_name: Ronald Emkey

given: Ronald

family: Butler

full_name: Peter W. Butler

given: Peter W.

family: Yin

full_name: Xiang Yin

given: Xiang

name: VU University Medical Center Amsterdam The Netherlands

family: Lems

full_name: Willem F. Lems

given: Willem F.

journal_name: Arthritis & Rheumatology

title: Denosumab Versus Risedronate in Glucocorticoid‐Induced Osteoporosis: Final Results of a Twenty‐Four–Month Randomized, Double‐Blind, Double‐Dummy Trial

lead_sponsor: Amgen

location_country:
United States
Mexico
Netherlands
Germany
France
Czechia
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
Denmark
Canada
Korea, Republic of
Colombia

acronym: GIOP

title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

summary: This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

summary:
The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult patients with migraine and major depressive disorder (MDD)

The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult patients with migraine and MDD on the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult patients with migraine and MDD.

The total duration of patient participation in the study is planned to be approximately 28 weeks.

primary_purpose: Prevention

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
United States
Finland
France
Czechia
Greece
Israel
Poland
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility:
Teva Investigational Site 14335
Teva Investigational Site 14330
Teva Investigational Site 32736
Teva Investigational Site 40057
Teva Investigational Site 31274
Teva Investigational Site 30237
Teva Investigational Site 58320
Teva Investigational Site 31273
Teva Investigational Site 53445
Teva Investigational Site 14343
Teva Investigational Site 14332
Teva Investigational Site 54184
Teva Investigational Site 32731
Teva Investigational Site 40056
Teva Investigational Site 32737
Teva Investigational Site 58319
Teva Investigational Site 54183
Teva Investigational Site 40055
Teva Investigational Site 14345
Teva Investigational Site 80172
Teva Investigational Site 50482
Teva Investigational Site 80175
Teva Investigational Site 14331
Teva Investigational Site 14338
Teva Investigational Site 14334
Teva Investigational Site 31272
Teva Investigational Site 14333
Teva Investigational Site 32733
Teva Investigational Site 34254
Teva Investigational Site 35265
Teva Investigational Site 50480
Teva Investigational Site 14336
Teva Investigational Site 14339
Teva Investigational Site 30236
Teva Investigational Site 53446
Teva Investigational Site 30242
Teva Investigational Site 35267
Teva Investigational Site 32734
Teva Investigational Site 30234
Teva Investigational Site 80173
Teva Investigational Site 54190
Teva Investigational Site 54186
Teva Investigational Site 54185
Teva Investigational Site 14337
Teva Investigational Site 31276
Teva Investigational Site 80178
Teva Investigational Site 58321
Teva Investigational Site 63076
Teva Investigational Site 14340
Teva Investigational Site 32732
Teva Investigational Site 30232
Teva Investigational Site 14329
Teva Investigational Site 40058
Teva Investigational Site 50481
Teva Investigational Site 14341
Teva Investigational Site 50483
Teva Investigational Site 80177
Teva Investigational Site 14411
Teva Investigational Site 63077
Teva Investigational Site 53447
Teva Investigational Site 53448


type: Registry Identifier

title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

acronym: POETYK PSO-LTE

summary: The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Sweden
Spain
Germany
Finland
France
Czechia
Japan
Israel
Poland
Hungary
Australia
Puerto Rico
New Zealand
China
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Dermatology and Skin Surgery Center - Exton

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Klinika Kozhnykh I Venericheskikh Bolezney

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Marietta Dermatology & The Skin Cancer Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: St. George Dermatology & Skin Care Centre

location_facility: The Centre for Dermatology - Richmond Hill

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Japan Community Health Care Organization Tokyo Yamate Medical Center

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: Ars Vitae Multidisciplinary Medical Center

location_facility: NIARMEDIK - Clinic on Clinic on Kitai Gorod

location_facility: Polyclinic of Private Security Personnel

location_facility: First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Olympian Clinical Research - Tampa Office

location_facility: Austin Institute for Clinical Research - Pflugerville

location_facility: Synexus - Lancashire Clinical Research Centre

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology

location_facility: Treasure Valley Dermatology & Skin Cancer Center

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: University California at Irvine Dermatology Clinical Research Center

location_facility: Clinical Research Center of the Carolinas

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula

location_facility: University of California San Diego Health Systems

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Northwest Arkansas Clinical Trials Center, PLLC

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Clinical Research Advantage - Evansville - South Kenmore Drive

location_facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

location_facility: University Hospital - Kyoto Preferctural University of Medicine

location_facility: Center for Clinical Studies - Texas Medical Center

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Associated Skin Care Specialists - Minnesota Clinical Study Center

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary

location_facility: Dermatology Treatment and Research Center

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov

location_facility: Clinic of Skin Diseases of Pierre Wolkenstein

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: SBHI Clinical Skin and Venereology Dispensary of the Ministry of Health of Krasnodar Region


title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus

summary: This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Guatemala
Malaysia
Belgium
Russian Federation
Ukraine
Costa Rica
France
Poland
Canada
Colombia
United Arab Emirates
Saudi Arabia
Philippines
Hungary
United States
United Kingdom
Mauritius
Italy
Mexico
Dominican Republic
Israel
Turkey

location_facility: Bashkir State Medical University Hospital ( Site 1603)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0705)

location_facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1001)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)

location_facility: Cliniques Universitaires Saint-Luc ( Site 2300)

location_facility: I. U. Cerrahpasa Tip Fakultesi ( Site 2406)

location_facility: Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)

location_facility: Children's Hospital - Los Angeles ( Site 2201)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)

location_facility: Rashid Center For Diabetes and Research ( Site 2006)

location_facility: Instytut Diabetologii Sp z o o ( Site 1512)

location_facility: St.Petersburg State Pediatric Medical University ( Site 1600)

location_facility: Chelsea and Westminster Hospital ( Site 2103)

location_facility: Center of Excellence in Diabetes and Endocrinology ( Site 2203)

location_facility: Thumbay University Hospital ( Site 2001)

location_facility: Voronezh State Medical University named after N.N.Burdenko ( Site 1608)

location_facility: MHI Regional Childrens Clinical Hospital ( Site 1908)

location_facility: King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0709)

location_facility: Federal State Budget Institution Endocrinological Research Center ( Site 1611)

location_facility: Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)

location_facility: Kazan State Medical University ( Site 1601)

location_facility: Al Jalila Children s Specialty Hospital ( Site 2004)

location_facility: Bio Investigación AMARC, S.C. ( Site 1006)

location_facility: Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)

location_facility: Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)

location_facility: King Abdulaziz Medical City - Al Ahsa ( Site 1730)

location_facility: The University of Alabama at Birmingham ( Site 2207)

location_facility: Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)

location_facility: Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)

location_facility: University Malaya Medical Centre ( Site 1100)

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)

location_facility: Children's City Clinical Hospital #1 ( Site 1604)

location_facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)

location_facility: King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)

location_facility: West Middlesex University Hospital ( Site 2104)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

location_facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

location_facility: Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)

location_facility: Cukurova Uni. Tip Fakultesi ( Site 2403)

location_facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1705)

location_facility: Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)

location_facility: Institute for Studies on Diabetes Foundation Inc. ( Site 1402)

location_facility: Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)

location_facility: Clinical Medical Research Sp. z o.o. ( Site 1511)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)

location_facility: Hospital Universiti Sains Malaysia ( Site 1102)

location_facility: The Edmond and Lily Safra Children s Hospital ( Site 0804)

location_facility: Siberian State Medical University ( Site 1602)

location_facility: Coastal Children''s Services ( Site 2202)

location_facility: Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (

location_facility: Odessa Regional Children Clinical Hospital ( Site 1912)

location_facility: Southern Endocrinology and Associates PA ( Site 2218)

location_facility: London Health Sciences Centre ( Site 0002)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)

location_facility: The Children's Hospital of Philadelphia ( Site 2205)

location_facility: West Visayas State University Medical Center ( Site 1401)

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 1000)

location_facility: Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)

location_facility: Soroka University Medical Center ( Site 0802)

location_facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1700)

location_facility: Royal London Hospital (Whitechapel) ( Site 2100)

location_facility: Centro de Atencion e Investigacion Clinica SC ( Site 1009)

location_facility: CAIMED Investigación en Salud S.A de C.V ( Site 1008)

location_facility: MedPlus Medicina Prepagada S.A. ( Site 0102)

location_facility: Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)

location_facility: Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)

location_facility: Unidad de Medicina Especializada SMA ( Site 1004)

location_facility: Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)

location_facility: King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)

location_facility: ICCT Research International, Inc. ( Site 2211)


title: A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

summary: The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
Italy
France
Spain
United States
United Kingdom
Portugal

location_facility:
HCA Healthcare UK
UT Southwestern
Centre Leon Berard
Mayo Clinic - FL
MD Anderson
Ospedale E. Agnelli
Istituto Europeo Di Oncologia - IEO
Champalimaud Clinical Center
Mayo Clinic - MN
Dana Farber Cancer Institute
Mayo Clinic - AZ
Florida Cancer Specialists
START Madrid - CIOCC
Tennessee Oncology
Institut Gustave Roussy
Massachusetts General Hospital
START Madrid - FJD
Istituto Nazionale Tumori Regina Elena
The Royal Marsden NHS Foundation Trust
The Christie NHS Foundation Trust
HCA Midwest Health


title: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

acronym: BE VITAL

summary: This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

status: Enrolling by invitation

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Italy
United States
Germany
France
Czechia
Japan
Poland
Hungary
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom

status_simplified: Unknown


title: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment

acronym: PATTERN

summary:
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Italy
Switzerland
Germany
France
Czechia
Poland
Norway
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom

location_facility: Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022

location_facility: New England institute for clinical research; Merz Investigational Site #0010441

location_facility: Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302

location_facility: Fakultni nemocnice Kralovske Vinohrady, Neurology Department, Merz Investigational Site #4200050

location_facility: Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017

location_facility: Centre Hospitalier Universitaire Vaudois - Neurorehabilitation and Physical Medicine, Merz Investigational Site #0410013

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018

location_facility: Federal State Autonomous Institution "National Medical Research Centre "Treatment and Rehabilitation" of the Ministry of Health of the Russian Federation, Neurology department, Merz Investigational Site # 0070305

location_facility: Hospital Universitario La Paz, Merz Investigational Site #0340007

location_facility: Neurologie Bewegt; Merz Investigational site #0490378

location_facility: University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211

location_facility: CBBM, Institut für Neurogenetik, Haus 66; Merz Investigational Site #0490332

location_facility: NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101

location_facility: Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023

location_facility: Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059

location_facility: Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University n.a. Professor V.F. Voino-Yasenetskiy of Ministry Healthcare of Russian Federation", Merz Investigational Site #0070306

location_facility: Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096

location_facility: Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049

location_facility: Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071

location_facility: UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082

location_facility: Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191

location_facility: Mazowiecki Szpital Brodnowski, Merz investigational site #0480064

location_facility: St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004

location_facility: The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004

location_facility: Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237

location_facility: Sunnaas Rehabilitation Hospital, Merz Investigational Site #0470002

location_facility: IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020

location_facility: DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081

location_facility: Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283

location_facility: Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063

location_facility: UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008

location_facility: Ospedale Valduce, Villa Beretta Rehabilitation Center, Merz investigational site #0390005

location_facility: Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003

location_facility: Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047

location_facility: Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191

location_facility: Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023

location_facility: UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013

location_facility: Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002

location_facility: Federal State Budgetary Institution "National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, Merz Investigational Site #0070009

location_facility: AOUI -Ospedale Borgo Roma, U.O.C Neuroriabilitazione, Merz Investigational Site #0390014

location_facility: Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079

location_facility: University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183

location_facility: Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation; Merz Investigational Site #0330018

location_facility: Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099

location_facility: Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100

location_facility: State Autonomous Institution of Healthcare of Moscow City "Moscow Scientific and Practical Centre of Medical Rehabilitation, Regenerative and Sports Medicine of Moscow City Healthcare Department", Merz Investigational Site #0070011

location_facility: Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199

location_facility: Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440

location_facility: Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077

location_facility: National Hospital for Neurology and Neurosurgery - UCLH; Merz Investigational Site #0440033


ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Finland
Malaysia
Greece
Belgium
Russian Federation
Taiwan
India
France
Japan
Lithuania
Poland
Slovakia
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Switzerland
Philippines
United States
Germany
United Kingdom
Italy
Spain
Estonia

location_facility: Hyogo prefectural Kobe Children's Hospital

location_facility: Department of Pediatrics, Christian Medical College and Hospital

location_facility: Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Urological Associates of Southern Arizona

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Dokkyo Medical University Hospital / Urology

location_facility: ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

location_facility: The University of Tokyo Hospital / Urology

location_facility: Children's Republican Clinical Hospital, Department of Pediatric Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: University General Hospital of Larisa/ Urology Department

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas klinikos

location_facility: SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

location_facility: Aichi Children's Health and Medical Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitair Ziekenhuis Antwerpen, Urologie

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical

location_facility: Centre hospitalier universitaire (CHU) Sainte-Justine

location_facility: FGBNU Scientific center of children health

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Groupement Hospitalier Est - Hopital Femme Mere Enfant

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

location_facility: Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

location_facility: Specjalistyczny Gabinet Lekarski Paweł Kroll

location_facility: I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche

location_facility: Osaka Medical Center and Research Institute for Maternal and Child Health

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

title: A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)

summary: The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.


title: Aneurysm Study of Pipeline in an Observational Registry

acronym: ASPIRE

summary: The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Italy
United States
Switzerland
Germany
France
Belgium
Argentina
Canada

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Abbott Northwestern Hospital/Consulting Radiologists

location_facility: Neurosurgical Associates at Central Baptist

location_facility: University of Buffalo Neurosurgery, Buffalo General Hospital

location_facility: The State University of New York, Stony Brook

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Ospedale San Giovanni Bosco ASL Napoli 1 Centro

location_facility: Medical College Of Wisconsin/Froedtert Hospital

location_facility: Radiology Imaging Associates / Colorado Neurological Institute

intervention_type: Device


intervention_type: Other

status: Active, not recruiting

location_country:
Netherlands
Spain
Germany
France
Czechia
Bulgaria
Japan
Poland
Hungary
Belgium
China
Turkey
United States
United Kingdom

acronym: BE MOBILE 2

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

summary: The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).


title: PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

summary: CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

lead_sponsor: Aeglea Biotherapeutics

location_country:
Italy
Austria
Germany
France
United States
United Kingdom
Canada

location_facility: Cohen Children's Medical Center (Northwell Health)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of Texas Health Science Center Medical School at Houston

location_facility: University of Florida College of Medicine

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Great Ormond Street Hospital for Children


lead_sponsor: ProQR Therapeutics

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Belgium
Canada
United Kingdom

acronym: ILLUMINATE

location_facility: Eye Clinic University of Campania Luigi Vanvitelli

location_facility: University of Miami - Bascom Palmer Eye Institute

location_facility: Moorfields Eye Hospital - NHS Foundation Trust

location_facility: Amsterdam University Medica Center - Locatie AMC

location_facility: University of Tuebingen - Inst. for Ophthalmic Research

location_facility: The Hospital for Sick Children - SickKids

location_facility: McGill University Health Centre - Centre for Innovative Medicine

location_facility: Casey Eye Institute - Oregon Health & Science University

location_facility: INRET Clínica/ Santa Casa de Misericórdia de Belo Horizonte

location_facility: Justus-Liebig Universität - Department of Ophthalmology

location_facility: Federal University of São Paulo - Hospital São Paulo (UNIFESP-HSP)

location_facility: Centre de maladies rares CHNO des Quinze Vingt

location_facility: University of Pennsylvania - Center for Advanced Retinal & Ocular Therapeutics

title: Double-masked, Randomized, Controlled, Multiple-dose Study to Evaluate Efficacy, Safety, Tolerability and Syst. Exposure of QR-110 in Leber's Congenital Amaurosis (LCA) Due to c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene

summary: The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment


ipd_sharing_description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

acronym: BE OPTIMAL

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

summary: This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).


title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension

summary: This study will evaluate the long-term safety and efficacy of Bimatoprost SR in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan

location_country:
Peru
Belgium
Russian Federation
Denmark
Spain
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Philippines
Singapore
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Egypt
New Zealand
Turkey

location_facility: Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

location_facility: Medical Center Ophthalmology Associates /ID# 240208

location_facility: Tel Aviv Sourasky Medical Center /ID# 240311

location_facility: Eye Associates of New Mexico /ID# 240216

location_facility: Hospital Universitario Austral /ID# 240331

location_facility: International Research Center /ID# 240346

location_facility: Hospital de Olhos de Mato Grosso Do Sul /ID# 240276

location_facility: Bostan Diagnostic Eye Center /ID# 240268

location_facility: Thammasat University Hospital /ID# 240231

location_facility: New York Presbyterian Hospital Weill Cornell Medical Center /ID# 240324

location_facility: Scott and Christie and Associates /ID# 240189

location_facility: Emerson Clinical Research Institute. LLC /ID# 240274

location_facility: S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251

location_facility: Clinical Eye Research of Boston LLC /ID# 240203

location_facility: Wolstan & Goldberg Eye Associates /ID# 240221

location_facility: Clinica De Oftalmologia Nova Campinas /ID# 240271

location_facility: Nature Coast Clinical Research - Crystal River /ID# 240334

location_facility: Clinica de Oftalmologia Sandiego /ID# 240233

location_facility: Internationale Innovative Ophthalmochirurgie /ID# 240232

location_facility: Pretoria Eye Institute - Private Practice /ID# 240223

location_facility: Rochester Ophthalmological Group PC /ID# 240290

location_facility: Universitaetsklinikum Magdeburg /ID# 240314

location_facility: Arizona Glaucoma Specialists /ID# 240212

location_facility: Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

location_facility: Fundacion Oftalmologica Nacional /ID# 240226

location_facility: The Chinese University of Hong Kong /ID# 240283

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240287

location_facility: Peregrine Eye and Laser Institute /ID# 240260

location_facility: Hospital das Clinicas da Universidade Federal de Goiás /ID# 240344

location_facility: Azienda Sanitaria Locale (ASL) Chieti /ID# 240217

location_facility: The Clinical Trials Network (CTNx) /ID# 240284

location_facility: Azienda Ospedaliera di Perugia /ID# 240310

location_facility: Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

location_facility: Glaucoma associates/consultants of the capital region /ID# 240195

location_facility: Hospital Oftalmologico Medicina dos Olhos /ID# 240277

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

location_facility: Levenson Eye Associates Inc. /ID# 240209

location_facility: Centre Ophtalmologique Pôle Vision /ID# 240256

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 240351

location_facility: Albemarle Clinical Trials LLC /ID# 240219

location_facility: Charlotte Eye,Ear,Nose Throat /ID# 240339

location_facility: Ophthalmic Consultants Long Island /ID# 240211

location_facility: The Lady Davis Carmel Medical Center /ID# 240293

location_facility: Ain Shams University Hospital /ID# 240338

location_facility: Seoul National University Hospital /ID# 240262

location_facility: Eskisehir Osmangazi University Medical School /ID# 240225

location_facility: Hospital Clinico Universitario San Carlos /ID# 240303

location_facility: Maharaj Nakorn Chiang Mai Hospital /ID# 240194

location_facility: Eye Associates of Fort Meyers /ID# 240218

location_facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253

location_facility: Universitair Ziekenhuis Leuven /ID# 240312

location_facility: DCT Shah Eye Research Institut /ID# 240306

location_facility: Optinum Profesorskie Centrum Okulistyki /ID# 240307

location_facility: Hospital Universitario Virgen Macarena /ID# 240325

location_facility: Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181

location_facility: Logan Ophthalmic Research Inc. /ID# 240280

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 240248

location_facility: Singapore National Eye Centre /ID# 240224

location_facility: Ophthalmic Consultant Centres /ID# 240205

location_facility: Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 240301

location_facility: Moorfields Eye Hospital NHS Foundation Trust /ID# 240329

location_facility: Hospital Universitario Reina Sofia /ID# 240322

location_facility: Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 240316

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305


title: A Phase Ib, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression

summary: CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
United States
France
Spain

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia


intervention_type: Biological

location_country:
Brazil
United States
Sweden
Saudi Arabia
Germany
France
Japan
Greece
Australia
Turkey
Canada
United Kingdom
Taiwan

location_facility: St. Vincent Hospital & Health Care Center, Inc.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Center for Child Health and Development

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIO

location_facility: Indiana Hemophilia and Thrombosis Center, Inc

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Universitätsklinikum Bonn, Anstalt des öffentlichen Rechts

location_facility: Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

location_facility: Gaziantep University Sahinbey Training and Research Hospital

location_facility: University of California, San Francisco - Clinical Research Center

location_facility: Juravinski Hospital - Hamilton Health Sciences

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Penn Comprehensive Hemophilia & Thrombosis Program, Hospital of University of Pennsylvania

location_facility: Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics

location_facility: Mississippi Center for Advanced Medicine

location_facility: University of California, San Francisco - Investigational Drug Service (IDS) Pharmacy

location_facility: Hopital Cardiologique Louis Pradel - CRTH

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

title: PHASE 3, OPEN LABEL, SINGLE ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF FIX GENE TRANSFER WITH PF-06838435 (RAAV-SPARK100-HFIX-PADUA) IN ADULT MALE PARTICIPANTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C <=2%) (BENEGENE-2)

summary: This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objectives of the study are to compare the annualized bleeding rate [ABR] of the gene therapy to routine prophylaxis from the lead-in study and to evaluate the impact that it may have on participant's Factor IX circulating activity [FIX:C].


title: A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria

summary: The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

lead_sponsor: Dicerna Pharmaceuticals, Inc.

location_country:
Italy
United States
Lebanon
Netherlands
Germany
France
Japan
Poland
Israel
Romania
Australia
New Zealand
Spain
Canada
United Kingdom


title: Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial

summary: A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS)who have completed the ORARIALS-01 trial.

ipd_sharing: Undecided

lead_sponsor: Orphazyme

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Poland
Belgium
Spain
Canada
United Kingdom

location_facility: Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422

location_facility: Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11

location_facility: University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: Hospital Carlos III - Hospital Universitario La Paz, ALS Unit

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen

location_facility: Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac


title: A Multi-center, Prospective, Longitudinal, Observational Study to Investigate the Clinical and Anthropometric Characteristics of Children With the Diagnosis Achondroplasia.

summary:
This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, & treatments

Children's information will be collected in the registry for a maximum of 5 years.

location_country:
Italy
United States
Switzerland
Spain
Germany
France
Japan
Belgium
Australia
Portugal
Denmark
Canada
United Kingdom

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Centre Hospitalier Univesitaire La Timone

location_facility: Guy's & St Thomas NHS Trust, St Thomas' Hospital

location_facility: Center for Rare Diseases, Department of Pediatrics, Polo Salute Donna e Bambino

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Center for Rare Skeletal Diseases in Childhood and Adolescence

location_facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Newcastle Hospitals NHS Foundation Trust

location_facility: Alfred I. duPont Hospital for Children - Wilmington

location_facility: Centre Hospitalier Universitaire Vaudois -CHUV


title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

summary: Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: MedImmune LLC

location_country:
Italy
Switzerland
Spain
France
Portugal
United States
Canada

intervention_type: Combination Product


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

summary: The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027

location_country:
United States
Sweden
France
Germany
Canada

location_facility: Palm Beach Neurological Center Advanced Research Consultants

location_facility: Associated Neurologists Of Southern Connecticut, P.C.

location_facility: Alexian Brothers Neurosciences Institute Clinical Research

location_facility: Hospital Of The University Of Pennsylvania


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

location_country:
United States
France
Czechia
Poland
Australia
New Zealand
China
Denmark
Canada
United Kingdom
Taiwan

acronym: RUBATO OL

location_facility: The Prince Charles Hospital, Adult Congenital Heart Disease Unit

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Providence Medical Research Providence Health Care

location_facility: Massachusetts General Hospital Heart Center

title: Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects

summary: The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bendamustine and Rituximab (BR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously treated patients with chronic lymphocytic leukemia (CLL).

ReferenceCitation: Steurer M, Montillo M, Scarfò L, Mauro FR, Andel J, Wildner S, Trentin L, Janssens A, Burgstaller S, Frömming A, Dümmler T, Riecke K, Baumann M, Beyer D, Vauléon S, Ghia P, Foà R, Caligaris-Cappio F, Gobbi M. Olaptesed pegol (NOX-A12) with bendamustine and rituximab: a phase IIa study in patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2019 Oct;104(10):2053-2060. doi: 10.3324/haematol.2018.205930. Epub 2019 May 16.

family: Steurer

full_name: Michael Steurer

given: Michael

family: Montillo

full_name: Marco Montillo

given: Marco

family: Scarfò

full_name: Lydia Scarfò

given: Lydia

family: Mauro

full_name: Francesca R. Mauro

given: Francesca R.

family: Andel

full_name: Johannes Andel

given: Johannes

family: Wildner

full_name: Sophie Wildner

given: Sophie

family: Trentin

full_name: Livio Trentin

given: Livio

family: Janssens

full_name: Ann Janssens

given: Ann

family: Burgstaller

full_name: Sonja Burgstaller

given: Sonja

family: Frömming

full_name: Anna Frömming

given: Anna

family: Dümmler

full_name: Thomas Dümmler

given: Thomas

family: Riecke

full_name: Kai Riecke

given: Kai

family: Baumann

full_name: Matthias Baumann

given: Matthias

family: Beyer

full_name: Diana Beyer

given: Diana

family: Vauléon

full_name: Stéphanie Vauléon

given: Stéphanie

family: Ghia

full_name: Paolo Ghia

given: Paolo

family: Foà

full_name: Robin Foà

given: Robin

family: Caligaris-Cappio

full_name: Federico Caligaris-Cappio

given: Federico

family: Gobbi

full_name: Marco Gobbi

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

name: College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea

name: D&D Pharmatech, Seongnam, Republic of Korea

name: College of Pharmacy, SungKyunKwan University, Suwon, Republic of Korea

title: Emerging PEGylated non-biologic drugs

location_facility: Hospices Civils, Department of Hematology

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: University Scientific Research Institute San Raffaele

location_facility: Centre Hospitalier Universitaire de la Milétrie, Department of Hematology

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: University Hospital Gasthuisberg, Department of Hematology

location_facility: University Hospital, Institute of Hematology and Oncology

location_facility: Azienda Sanitaria Locale 8, Department of Oncology

location_facility: Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology)

location_facility: Institute Jules Bordet, Department of Hematology

location_facility: Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology)

location_facility: University La Sapienza, Department of Cellular Biotechnologies and Hematology

location_facility: Centre Hospitalier Universitaire Clémenceau, Department of Hematology

location_facility: Medical University Innsbruck, Division of Hematology and Oncology

location_facility: University School of Medicine, Department of Hematology


title: Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures

acronym: VERVE

summary: The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

ReferenceCitation: Baulac M, Byrnes W, Williams P, Borghs S, Webster E, De Backer M, Dedeken P. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017 Apr;135(4):434-441. doi: 10.1111/ane.12691. Epub 2016 Oct 6.

name: Pitié-Salpêtrière Hospital; IHU-ICM; Paris France

family: Baulac

full_name: M. Baulac

given: M.

family: Byrnes

full_name: W. Byrnes

given: W.

family: Williams

full_name: P. Williams

given: P.

family: Borghs

full_name: S. Borghs

given: S.

family: Webster

full_name: E. Webster

given: E.

family: De Backer

full_name: M. De Backer

family: Dedeken

full_name: P. Dedeken

journal_name: Acta Neurologica Scandinavica

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

endpoint_id: HAL

repository_institution: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

lead_sponsor: UCB Pharma

location_country:
Sweden
Germany
France
Bulgaria
Romania
Australia
Spain
Denmark
United States


title: A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension

summary: The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2021 Aug 11. doi: 10.1007/s40262-021-01052-8. [Epub ahead of print]

family: Ferguson-Sells

full_name: Lisa Ferguson-Sells

given: Lisa

family: Velez de Mendizabal

full_name: Nieves Velez de Mendizabal

given: Nieves

family: Li

full_name: Baohui Li

given: Baohui

family: Small

full_name: David Small

given: David

journal_name: Clinical Pharmacokinetics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
France
Poland
Spain
United States
United Kingdom
Canada

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Children's Heathcare of Atlanta, Inc. at Egleston

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity

summary: This pivotal, phase 3 study is designed to confirm the efficacy and safety of setmelanotide, a potent melanocortin receptor type 4 (MC4R) agonist, for the treatment of obesity and hyperphagia in patients with Bardet Biedl syndrome (BBS) or Alström syndrome (AS). The study's primary efficacy endpoint will evaluate the proportion of patients (≥12 years of age at baseline) who lose ≥10% of their baseline body weight following approximately (~) 52 weeks of treatment with setmelanotide compared to a historical control rate. The study will consist of 3 treatment periods. Eligible patients will enter a 14 week, randomized, double-blind, placebo-controlled treatment period (Period 1) that will be followed by a 38 week open label treatment period (Period 2) in which all patients will receive setmelanotide. The primary analysis will be performed after Period 2. Following Period 2, patients will continue open-label treatment for 14 weeks (Period 3) after which they may be enrolled into a separate treatment extension study.

ReferenceCitation: Haws RM, Gordon G, Han JC, Yanovski JA, Yuan G, Stewart MW. The efficacy and safety of setmelanotide in individuals with Bardet-Biedl syndrome or Alström syndrome: Phase 3 trial design. Contemp Clin Trials Commun. 2021 May 3;22:100780. doi: 10.1016/j.conctc.2021.100780. eCollection 2021 Jun.

family: Haws

full_name: Robert M. Haws

given: Robert M.

family: Gordon

full_name: Gregory Gordon

given: Gregory

family: Han

full_name: Joan C. Han

given: Joan C.

family: Yanovski

full_name: Jack A. Yanovski

given: Jack A.

family: Yuan

full_name: Guojun Yuan

given: Guojun

family: Stewart

full_name: Murray W. Stewart

given: Murray W.

journal_name: Contemporary Clinical Trials Communications

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
France
Puerto Rico
Spain
United States
United Kingdom
Canada

location_facility: Sorbonne University Pitié-Salpêtrière Hospital

location_facility: UMMS Baystate Health; BAYSTATE MEDICAL CENTER; Baystate Children's Specialty Center

location_facility: University of Tennessee Health Science Center

location_facility: Universidad Autónoma de Madrid University Hospital Niño


lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Greece
Romania
Russian Federation
Taiwan
Ukraine
Thailand
France
Poland
Chile
Philippines
Bulgaria
Hungary
United States
United Kingdom
Italy
Mexico
Czechia
Israel
Georgia
Spain
Turkey

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: National Institute of Endocrinology - Prof. Elene Giorgadze Clinic

location_facility: Clinical Rheumatological Hospital Number 25

location_facility: University Multiprofile Hospital for Active Treatment Pulmed

location_facility: UBAM Unidad Biomédica Avanzada Monterrey

location_facility: Centro de Investigación Clínica GRAMEL, S.C.

location_facility: Polyclinic of Private Security and Detectives

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet

location_facility: Unidad de Investigaciones Reumatológicas A.C.

location_facility: Valerius Medical Group and Research Center

location_facility: Paramount Medical Research and Consulting

location_facility: Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,

location_facility: Advanced Research Institute Inc Allergy & Rheumatology

location_facility: Hospital Universitario Regional de Málaga

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Far Eastern University - Nicanor Reyes Medical Foundation

location_facility: Hospital Universitario "Dr. Gonzalo Valdés Valdés"

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Morales Vargas Centro de Investigación S.C.

location_facility: State University of New York Upstate Medical University

location_facility: Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"

location_facility: City Clinical Hospital #15 named after O.M. Filatova

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Private Small Scale Medical Center "Pulse"

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

location_facility: North Georgia Rheumatology Group - Duluth

location_facility: Poltava Regional Clinical Hospital named after M.V. Sklifossovsky

location_facility: Diagnostic and Consulting Center "Aleksandrovska" EOOD

location_facility: University of Colorado School of Medicine

location_facility: Joint Muscle Medical Care and Research Institute - Lilington Office

location_facility: Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"

location_facility: Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"

location_facility: Unidad de Atención Médica e Investigación en Salud

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Washington University School of Medicine

location_facility: Consultorio Particular Dr. Miguel Cortés Hernández

location_facility: Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department

location_facility: Vinnytsya Regional Clinical Hospital - Rheumatology Department

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie

location_facility: Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

location_facility: Consultorio Médico del Dr. Federico Galván Villegas

location_facility: Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi

location_facility: Multiprofile Hospital For Active Treatment Trimontium

location_facility: Angeles University Foundation Medical Center

location_facility: State Institution of Health Protection "Clinical Hospital #8"

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Center for Rheumatology Immunology and Arthritis

location_facility: Centro Integral en Reumatología S.A. de C.V.

location_facility: Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá

location_facility: University of the Philippines Manila - Philippine General Hospital

location_facility: Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"

location_facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

location_facility: Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways

location_facility: Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"

location_facility: Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

location_facility: Ternopil University Clinic - Rheumatology department

title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

summary: The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).