Summary

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

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 Sclerosis RPC1063

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

  • Multiple Sclerosis Center at UCSF
    San Francisco California 94158 United States
  • Neuro Pain Medical Center
    Fresno California 93710 United States

Lead Scientist

  • Bruce Cree
    Bruce Cree, MD, PhD, MAS is a Professor of Clinical Neurology and is the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. Dr. Cree completed his MD and PhD in Biochemistry at UCSF. His neurology residency training was at Columbia University.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02576717
Phase
Phase 3
Study Type
Interventional
Last Updated