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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Receptos, Inc.
ClinicalTrials.gov Identifier:
NCT01628393
First received: June 22, 2012
Last updated: January 17, 2014
Last verified: January 2014

June 22, 2012
January 17, 2014
July 2012
May 2014   (final data collection date for primary outcome measure)
Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01628393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study)
A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • Drug: RPC1063
    oral, low dose, daily for 24 weeks
  • Drug: placebo
    oral, 1 capsule, daily for 24 weeks
  • Drug: RPC1063
    oral, high dose, daily for 24 weeks
  • Experimental: RPC1063 Low Dose
    Intervention: Drug: RPC1063
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: RPC1063 High Dose
    Intervention: Drug: RPC1063
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
Not Provided
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
  • EDSS score between 0 and 5.0 at baseline

Exclusion Criteria:

  • Secondary or primary progressive multiple sclerosis
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Georgia,   Greece,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Ukraine
 
NCT01628393
RPC01-201 (Part A), 2012-002714-40
Yes
Receptos, Inc.
Receptos, Inc.
Not Provided
Not Provided
Receptos, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP