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Summary

for people ages 18–55 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

Official Title

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

Details

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

Keywords

Multiple Sclerosis MS RMS Relapsing Multiple Sclerosis

Eligibility

For people ages 18–55

Eligibility Criteria:

  • Completed one of the parent trials: RPC01-201, RPC01-301 or RPC01-1001
  • Does not have a condition that would require withdrawal from one of the parent trials(RPC01-201, RPC01-301, RPC01-1001)
  • Has no conditions requiring treatment with a prohibited medication
  • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  • Patients of reproduction potential (males and females) must practice an acceptable method of birth control

Locations

  • Neuro Pain Medical Center
    Fresno, California, 93710, United States
  • Alta Bates Summit Medical Center
    Berkeley, California, 94705, United States
  • University of California Davis Medical Center
    Sacramento, California, 95817, United States
  • Collaborative Neuroscience Network Inc
    Long Beach, California, 90806, United States
  • Cleveland Clinic Lou Ruvo Center for Brain Health
    Las Vegas, Nevada, 89106, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02576717
Phase
Phase 3
Lead Scientist
Bruce Cree
Study Type
Interventional
Last Updated
July 1, 2017