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NCT01628393 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

A Phase 2 study of Relapsing Multiple Sclerosis, sponsored by Celgene.

Completed
Registry status
Phase 2
Development phase
258
Enrollment target
20
Study locations

NCT01628393 is a Phase 2 study of Relapsing Multiple Sclerosis that has completed, run by Celgene. The registered enrollment target is 258 participants, below the 2,158-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT01628393, a Phase 2 study of Relapsing Multiple Sclerosis, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 2
Development phase
258 participants
Enrollment target
20
Study locations

Study Summary

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Conditions Studied

Relapsing Multiple Sclerosis

Interventions

  • DRUG Placebo
  • DRUG Ozanimod

Study Locations (20)

Other

  • Cliniques Universitaires St-Luc - Brussels
  • Centre Hospitalier Chretien Clinique Saint Joseph - Montegnée
  • Clinique Saint-Pierre - Ottignies
  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD - Sofia
  • Sarajishvili Institute of Neurology - Tbilisi
  • LTD MediClubGeorgia - Tbilisi
  • Khechinashvili University Hospital - Tbilisi
  • Evaggelismos General Hospital - Athens
  • 401 Military Hospital of Athens - Athens
  • Georgios Papanikolaou General Hospital of Thessaloniki - Thessaloniki
  • Vaszary Kolos Korhaz - Esztergom
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Cantania
  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi - Czeladź
  • Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego - Grudziądz

California

  • Alta Bates Summit Medical Center - Berkeley
  • Neuro Pain Medical Center - Fresno
  • University of California Davis Medical Center - Sacramento

North Carolina

  • The Neurological Institute PA - Charlotte

Ohio

  • Neurology and Neuroscience Associates Inc. - Akron

Washington

  • The Polyclinic - Seattle

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2012-09-18
Est. Completion 2016-05-11
Phase Phase 2

Sponsor

Celgene

308 total trials

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What the Registry Record Tells You About NCT01628393

The ClinicalTrials.gov registry entry for NCT01628393 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,158-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (88% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01628393 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT01628393 about?

NCT01628393 is a clinical study titled "Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients". This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enh...

What is the current status of trial NCT01628393?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-09-18. Estimated completion is 2016-05-11.

What conditions does trial NCT01628393 study?

This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.

What interventions are being tested in trial NCT01628393?

The interventions under investigation include: Placebo (DRUG), Ozanimod (DRUG).

Who is sponsoring clinical trial NCT01628393?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01628393 being conducted?

This trial has 20 study locations across California, North Carolina, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.