Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

NCT ID: NCT02047734

Last Updated: 2021-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-03

Study Completion Date

2017-04-13

Brief Summary

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This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Detailed Description

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This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.

Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Conditions

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ozanimod 0.5 mg

Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Group Type EXPERIMENTAL

Ozanimod

Intervention Type DRUG

Oral capsule, daily for 24 months

Interferon beta-1a placebo

Intervention Type DRUG

Intramuscular injection, weekly for 24 months

Ozanimod1 mg

Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Group Type EXPERIMENTAL

Ozanimod

Intervention Type DRUG

Oral capsule, daily for 24 months

Interferon beta-1a placebo

Intervention Type DRUG

Intramuscular injection, weekly for 24 months

Interferon β-1a

interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.

Group Type ACTIVE_COMPARATOR

Ozanimod placebo

Intervention Type DRUG

Oral capsule, daily for 24 months

Interferon beta-1a

Intervention Type DRUG

Intramuscular injection, 30 µg, weekly for 24 months

Interventions

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Ozanimod

Oral capsule, daily for 24 months

Intervention Type DRUG

Ozanimod placebo

Oral capsule, daily for 24 months

Intervention Type DRUG

Interferon beta-1a

Intramuscular injection, 30 µg, weekly for 24 months

Intervention Type DRUG

Interferon beta-1a placebo

Intramuscular injection, weekly for 24 months

Intervention Type DRUG

Other Intervention Names

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RPC1063 Zeposia® Avonex

Eligibility Criteria

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Inclusion Criteria

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria

* Primary progressive multiple sclerosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Receptos Study Site 115

Phoenix, Arizona, United States

Site Status

Xenoscience

Phoenix, Arizona, United States

Site Status

Receptos Study Site 118

Phoenix, Arizona, United States

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Saint Josephs Hosptial and Medical Center

Phoenix, Arizona, United States

Site Status

Territory Neurology and Research Institute

Tucson, Arizona, United States

Site Status

Receptos Study Site 119

Tucson, Arizona, United States

Site Status

Alta Bates Summit Medical Center

Berkeley, California, United States

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Receptos Study Site 110

Berkeley, California, United States

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Receptos Study Site 122

Long Beach, California, United States

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Receptos Study Site 112

Sacramento, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

Multiple Sclerosis Center at UCSF

San Francisco, California, United States

Site Status

Receptos Study Site 120

San Francisco, California, United States

Site Status

Denver Neurological Research LLC

Denver, Colorado, United States

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Receptos Study Site 127

Denver, Colorado, United States

Site Status

Neurology Associates PA

Maitland, Florida, United States

Site Status

Receptos Study Site 114

Maitland, Florida, United States

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Receptos Study Site 124

Pompano Beach, Florida, United States

Site Status

Neurostudies Inc

Port Charlotte, Florida, United States

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Receptos Study Site 123

Port Charlotte, Florida, United States

Site Status

Infinity Clinical Research LLC

Sunrise, Florida, United States

Site Status

West Georgia Sleep Disorder Center and Neurology Associates

Douglasville, Georgia, United States

Site Status

Consultants In Neurology

Northbrook, Illinois, United States

Site Status

Receptos Study Site 113

Northbrook, Illinois, United States

Site Status

Receptos Study Site 121

St Louis, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

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Receptos Study Site 101

Charlotte, North Carolina, United States

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The Neurological Institute PA

Charlotte, North Carolina, United States

Site Status

Neurology and Neuroscience Associates Inc.

Akron, Ohio, United States

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Receptos Study Site 107

Akron, Ohio, United States

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Receptos Study Site 104

Cleveland, Ohio, United States

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Receptos Study Site 109

Philadelphia, Pennsylvania, United States

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Receptos Study Site 102

Seattle, Washington, United States

Site Status

The Polyclinic

Seattle, Washington, United States

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Receptos Study Site 125

Tacoma, Washington, United States

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Grodno Clinical Regional Hospital

Grodno, , Belarus

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Receptos Study Site 907

Grodno, , Belarus

Site Status

Gomel Regional Clinical Hospital

Homyel, , Belarus

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Receptos Study Site 904

Homyel, , Belarus

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Minsk Municipal Clinical Hospital 5

Minsk, , Belarus

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Receptos Study Site 902

Minsk, , Belarus

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Receptos Study Site 901

Minsk, , Belarus

Site Status

Republican Scientific and Practical Centre of Neurology and Neurosurgery

Minsk, , Belarus

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Minsk City Clinical Hospital 9

Minsk, , Belarus

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Receptos Study Site 903

Minsk, , Belarus

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Receptos Study Site 905

Vitebsk, , Belarus

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Vitebsk Regional Diagnostic Centre

Vitebsk, , Belarus

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Receptos Study Site 906

Vitebsk, , Belarus

Site Status

AZ Sint-Jan AV Brugge

Bruges, , Belgium

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Receptos Study Site 256

Bruges, , Belgium

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Cliniques Universitaires St Luc

Brussels, , Belgium

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Receptos Study Site 255

Brussels, , Belgium

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Centre Hospitalier Chretien Clinique Saint Joseph

Montegnée, , Belgium

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Receptos Study Site 252

Montegnée, , Belgium

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Clinique Saint Pierre

Ottignies, , Belgium

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Receptos Study Site 254

Ottignies, , Belgium

Site Status

Clinical Center University of Sarajevo

Sarajevo, , Bosnia and Herzegovina

Site Status

Receptos Study Site 911

Sarajevo, , Bosnia and Herzegovina

Site Status

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD

Sofia, , Bulgaria

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Receptos Study Site 453

Sofia, , Bulgaria

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Receptos Study Site 454

Sofia, , Bulgaria

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Receptos Study Site 452

Sofia, , Bulgaria

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Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

Sofia, , Bulgaria

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Receptos Study Site 456

Sofia, , Bulgaria

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Receptos Study Site 457

Sofia, , Bulgaria

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University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, , Bulgaria

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University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, , Bulgaria

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Receptos Study Site 451

Sofia, , Bulgaria

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University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

Sofia, , Bulgaria

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Receptos Study Site 455

Sofia, , Bulgaria

Site Status

University of Alberta MS Clinic

Edmonton, Alberta, Canada

Site Status

Receptos Study Site 154

Edmonton, Alberta, Canada

Site Status

Clinical Hospital Center Osijek

Osijek, , Croatia

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Receptos Study Site 923

Osijek, , Croatia

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Receptos Study Site 921

Zagreb, , Croatia

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Receptos Study Site 922

Zagreb, , Croatia

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Receptos Study Site 924

Zagreb, , Croatia

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Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases

Zagreb, , Croatia

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Clinical Hospital Centre Zagreb

Zagreb, , Croatia

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Clinical Hospital Sveti duh

Zagreb, , Croatia

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Receptos Study Site 301

Tbilisi, , Georgia

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LTD MediClubGeorgia

Tbilisi, , Georgia

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Receptos Study Site 302

Tbilisi, , Georgia

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Khechinashvili University Hospital

Tbilisi, , Georgia

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Receptos Study Site 303

Tbilisi, , Georgia

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Sarajishvili Institute of Neurology

Tbilisi, , Georgia

Site Status

Evaggelismos General Hospital

Athens, , Greece

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Receptos Study Site 552

Athens, , Greece

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Receptos Study Site 554

Athens, , Greece

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Navy Hospital of Athens

Athens, , Greece

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Receptos Study Site 553

Athens, , Greece

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401 Military Hospital of Athens

Athens, , Greece

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Receptos Study Site 551

Athens, , Greece

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AHEPA University General Hospital of Thessaloniki

Thessaloniki, , Greece

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Receptos Study Site 557

Thessaloniki, , Greece

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Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, , Greece

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Receptos Study Site 555

Thessaloniki, , Greece

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Receptos Study Site 352

Budapest, , Hungary

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Uzsoki Utcai Korhaz

Budapest, , Hungary

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Jahn Ferenc DelPesti Korhaz es Rendelointezet

Budapest, , Hungary

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Receptos Study Site 356

Budapest, , Hungary

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Receptos Study Site 354

Esztergom, , Hungary

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Vaszary Kolos Korhaz

Esztergom, , Hungary

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Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

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Receptos Study Site 358

Kistarcsa, , Hungary

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Receptos Study Site 351

Nyíregyháza, , Hungary

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SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

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Receptos Study Site 355

Székesfehérvár, , Hungary

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Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, , Italy

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Receptos Study Site 654

Catania, , Italy

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Fondazione Istituto San Raffaele G Giglio di Cefalu

Cefalù, , Italy

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Receptos Study Site 653

Cefalù, , Italy

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

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Receptos Study Site 655

Milan, , Italy

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Receptos Study Site 652

Milan, , Italy

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Presidio Ospedaliero di Montichiari

Montichiari, , Italy

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Receptos Study Site 659

Montichiari, , Italy

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Receptos Study Site 656

Napoli, , Italy

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Receptos Study Site 658

Pavia, , Italy

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Fondazione PTV Policlinico Tor Vergata

Roma, , Italy

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Receptos Study Site 651

Roma, , Italy

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Azienda Ospedaliera Universitaria Senese

Siena, , Italy

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Receptos Study Site 657

Siena, , Italy

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IMSP Institutul de Medicina Urgenta

Chisinau, , Moldova

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Receptos Study Site 932

Chisinau, , Moldova

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Institutul de Neurologie si Neurochirurgie

Chisinau, , Moldova

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Receptos Study Site 931

Chisinau, , Moldova

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Receptos Study Site 933

Chisinau, , Moldova

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Receptos Study Site 401

Bialystok, , Poland

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Receptos Study Site 423

Bydgoszcz, , Poland

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Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek

Bydgoszcz, , Poland

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Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi

Czeladź, , Poland

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Receptos Study Site 406

Czeladź, , Poland

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Receptos Study Site 405

Gdansk, , Poland

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Receptos Study Site 425

Gdansk, , Poland

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Copernicus PL Sp. z. o.o.

Gdansk, , Poland

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NEUROMEDIC Janusz Zbrojkiewicz

Katowice, , Poland

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MA LEK AM Maciejowscy SC Centrum Terapii SM

Katowice, , Poland

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Receptos Study Site 427

Katowice, , Poland

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NovoMed Zielinski i Wspolnicy Spolka Jawna

Katowice, , Poland

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Receptos Study Site 426

Katowice, , Poland

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NEUROCARE Site Management Organization Gabriela KlodowskaDuda

Katowice, , Poland

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Receptos Study Site 407

Katowice, , Poland

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Receptos Study Site 417

Katowice, , Poland

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Receptos Study Site 424

Kielce, , Poland

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RESMEDICA Spolka z o.o.

Kielce, , Poland

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Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny

Konstancin-Jeziorna, , Poland

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Receptos Study Site 404

Konstancin-Jeziorna, , Poland

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Krakowska Akademia Neurologii Sp. z. o.o.

Krakow, , Poland

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Receptos Study Site 414

Krakow, , Poland

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Centrum Neurologii Krzysztof Selmaj

Lodz, , Poland

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Receptos Study Site 411

Lodz, , Poland

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Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

Lublin, , Poland

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Receptos Study Site 412

Lublin, , Poland

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Receptos Study Site 420

Lublin, , Poland

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Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego

Lublin, , Poland

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Receptos Study Site 402

Olsztyn, , Poland

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Receptos Study Site 415

Olsztyn, , Poland

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Wojewodzki Szpital Specjalistyczny

Olsztyn, , Poland

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Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska

Plewiska, , Poland

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Receptos Study Site 421

Plewiska, , Poland

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Niepubliczny Zaklad Opieki Zdrowotnej KENDRON

Podlaskie, , Poland

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Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak

Pomorskie, , Poland

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Receptos Study Site 408

Poznan, , Poland

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Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

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Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, , Poland

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Receptos Study Site 418

Poznan, , Poland

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EUROMEDIS Sp. z.o.o.

Szczecin, , Poland

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Receptos Study Site 419

Szczecin, , Poland

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Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski

Warminsko-mazurskie, , Poland

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Receptos Study Site 410

Warsaw, , Poland

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Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Warsaw, , Poland

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Centrum Medyczne NeuroProtect

Warsaw, , Poland

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Receptos Study Site 428

Warsaw, , Poland

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Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, , Poland

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Receptos Study Site 422

Warsaw, , Poland

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Instytut Psychiatrii i Neurologii

Warsaw, , Poland

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Receptos Study Site 403

Warsaw, , Poland

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Receptos Study Site 413

Warsaw, , Poland

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Wojskowy Instytut Medyczny

Warsaw, , Poland

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Clinical Hospital of Psychiatry and Neurology Brasov

Brasov, , Romania

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Receptos Study Site 503

Brasov, , Romania

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Health Club Medical Center S.R.L.

Campulung Muscel, , Romania

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Receptos Study Site 502

Campulung Muscel, , Romania

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Receptos Study Site 501

Cluj-Napoca, , Romania

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Rehabilitation Clinical Hospital

Cluj-Napoca, , Romania

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Receptos Study Site 505

Sibiu, , Romania

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Sibiu Emergency County Clinical Hospital

Sibiu, , Romania

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Receptos Study Site 506

Timișoara, , Romania

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Timisoara Emergency County Clinical Hospital

Timișoara, , Romania

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Chelyabinsk City Clinical Hospital 3

Chelyabinsk, , Russia

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Receptos Study Site 701

Chelyabinsk, , Russia

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Receptos Study Site 704

Kazan', , Russia

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Republican Clinical Hospital for Rehabilitation Treatment

Kazan', , Russia

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Receptos Study Site 713

Kazan', , Russia

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Research Medical Complex Vashe Zdorovie

Kazan', , Russia

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Central Clinical Hospital 2 na NA Semashko OAO RZhD

Moscow, , Russia

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Receptos Study Site 712

Moscow, , Russia

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City Clinical Hospital 1 na NIPirogov

Moscow, , Russia

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Receptos Study Site 709

Moscow, , Russia

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City neurology center Sibneuromed LLC

Novosibirsk, , Russia

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Receptos Study Site 703

Novosibirsk, , Russia

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Perm State Medical Academy

Perm, , Russia

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Receptos Study Site 710

Perm, , Russia

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Receptos Study Site 708

Saint Petersburg, , Russia

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Russian Medical Military Academy na SMKirov

Saint Petersburg, , Russia

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Receptos Study Site 716

Samara, , Russia

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Samara Regional Clinical Hospital named after MI Kalinin

Samara, , Russia

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City Clinical Hospital 4

Saransk, , Russia

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Receptos Study Site 715

Saransk, , Russia

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Receptos Study Site 714

Saratov, , Russia

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Saratov State Medical University

Saratov, , Russia

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Receptos Study Site 707

Smolensk, , Russia

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Smolensk State Medical Academy

Smolensk, , Russia

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Receptos Study Site 717

Tyumen, , Russia

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Neftyanik Medical and Sanitary Unit

Tyumen, , Russia

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Receptos Study Site 711

Yaroslavl, , Russia

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Yaroslavl Clinical Hospital 8

Yaroslavl, , Russia

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Clinical Center of Serbia

Belgrade, , Serbia

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Clinical Hospital Centar Zvezdara

Belgrade, , Serbia

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Military Medical Academy

Belgrade, , Serbia

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Receptos Study Site 602

Belgrade, , Serbia

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Receptos Study Site 603

Belgrade, , Serbia

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Receptos Study Site 604

Belgrade, , Serbia

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Clinical Hospital Centre Zemun

Belgrade, , Serbia

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Receptos Study Site 601

Belgrade, , Serbia

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Clinical Center Kragujevac

Kragujevac, , Serbia

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Receptos Study Site 605

Kragujevac, , Serbia

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University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic

Bratislava, , Slovakia

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Receptos Study Site 946

Bratislava, , Slovakia

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Receptos Study Site 942

Lučenec, , Slovakia

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Receptos Study Site 945

Trnava, , Slovakia

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Receptos Study Site 956

KwaZulu-Natal, , South Africa

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Neurology Practice

Pretoria, , South Africa

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Receptos Study Site 953

Pretoria, , South Africa

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Receptos Study Site 755

Seville, Andalusia, Spain

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Receptos Study Site 761

Bilbao, Basque Country, Spain

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Receptos Study Site 759

Donostia / San Sebastian, Basque Country, Spain

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Receptos Study Site 763

Santa Cruz de Tenerife, Canary Islands, Spain

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Receptos Study Site 756

Barcelona, Catalonia, Spain

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Receptos Study Site 760

Girona, Catalonia, Spain

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Receptos Study Site 762

Alicante, Valencia, Spain

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Receptos Study Site 752

Valencia, Valencia, Spain

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Hospital General Universitario de Alicante

Alicante, , Spain

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Hospital del Mar

Barcelona, , Spain

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Receptos Study Site 758

Barcelona, , Spain

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Hospital Universitario Vall D hebron

Barcelona, , Spain

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Organizacion Sanitaria Integrada Bilbao Basurto

Bilbao, , Spain

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Hospital Universitari de Girona Dr Josep Trueta

Girona, , Spain

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Hospital Universitario de la Princesa

Madrid, , Spain

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Receptos Study Site 757

Madrid, , Spain

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Receptos Study Site 751

Madrid, , Spain

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Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

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Receptos Study Site 754

Majadahonda (Madrid), , Spain

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Hospital Universitario Vírgen Macarena

Seville, , Spain

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Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

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Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital

Chernihiv, , Ukraine

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Receptos Study Site 805

Chernihiv, , Ukraine

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Municipal Institution Chernivtsi Regional Psychiatric Hospital

Chernivtsi, , Ukraine

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Receptos Study Site 813

Chernivtsi, , Ukraine

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Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov

Dnipropetrovsk, , Ukraine

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Receptos Study Site 802

Dnipropetrovsk, , Ukraine

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State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

Dnipropetrovsk, , Ukraine

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Receptos Study Site 815

Dnipropetrovsk, , Ukraine

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Receptos Study Site 801

Ivano-Frankivsk, , Ukraine

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Regional Clinical Hospital

Ivano-Frankivsk, , Ukraine

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Receptos Study Site 814

Kharkiv, , Ukraine

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State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya

Kharkiv, , Ukraine

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Municipal Institution Kherson City Clinical Hospital

Kherson, , Ukraine

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Receptos Study Site 811

Kherson, , Ukraine

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Receptos Study Site 818

Kyiv, , Ukraine

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Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

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Receptos Study Site 803

Kyiv, , Ukraine

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Kyiv City Clinical Hospital 4

Kyiv, , Ukraine

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Municipal Institution Lutsk City Clinical Hospital

Lutsk, , Ukraine

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Receptos Study Site 816

Lutsk, , Ukraine

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Receptos Study Site 817

Lutsk, , Ukraine

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Volyn Regional Clinical Hospital

Lutsk, , Ukraine

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Lviv Regional Clinical Hospital

Lviv, , Ukraine

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Receptos Study Site 812

Lviv, , Ukraine

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Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU

Odesa, , Ukraine

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Receptos Study Site 810

Odesa, , Ukraine

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Municipal Institution Odesa Regional Clinical Hospital

Odesa, , Ukraine

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Receptos Study Site 804

Odesa, , Ukraine

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Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko

Vinnytsia, , Ukraine

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Receptos Study Site 809

Vinnytsia, , Ukraine

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Municipal Institution City Clinical Hospital 6

Zaporizhzhya, , Ukraine

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Receptos Study Site 806

Zaporizhzhya, , Ukraine

Site Status

Receptos Study Site 965

Brighton, , United Kingdom

Site Status

Royal Sussex County Hospital

Brighton East Sussex, , United Kingdom

Site Status

Raigmore Hospital

Inverness, , United Kingdom

Site Status

Receptos Study Site 963

Inverness, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Receptos Study Site 961

London, , United Kingdom

Site Status

National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Site Status

Receptos Study Site 967

London, , United Kingdom

Site Status

Receptos Study Site 966

Romford, , United Kingdom

Site Status

Receptos Study Site 964

Sheffield, , United Kingdom

Site Status

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

Sheffield, , United Kingdom

Site Status

Countries

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United States Belarus Belgium Bosnia and Herzegovina Bulgaria Canada Croatia Georgia Greece Hungary Italy Moldova Poland Romania Russia Serbia Slovakia South Africa Spain Ukraine United Kingdom

References

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Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344

Reference Type RESULT

Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Epub 2019 Sep 3.

Reference Type RESULT
PMID: 31492652 (View on PubMed)

Harris S, Comi G, Cree BAC, Arnold DL, Steinman L, Sheffield JK, Maddux R, Southworth H, Kappos L, Cohen JA. Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. Eur J Neurol. 2025 Jun;32(6):e70222. doi: 10.1111/ene.70222.

Reference Type DERIVED
PMID: 40462564 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2012-002714-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RPC01-201-PartB

Identifier Type: -

Identifier Source: org_study_id

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