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: June 3, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: RPC1063
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Receptos, Inc.:

Primary Outcome Measures:
  • Total number of new GdE lesions, assessed on brain MRIs [ Time Frame: Week 12 to Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: July 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPC1063 Low Dose Drug: RPC1063
oral, low dose, daily for 24 weeks
Placebo Comparator: placebo Drug: placebo
oral, 1 capsule, daily for 24 weeks
Experimental: RPC1063 High Dose Drug: RPC1063
oral, high dose, daily for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628393

  Hide Study Locations
Locations
United States, California
Berkeley, California, United States
Fresno, California, United States
Sacramento, California, United States
United States, Florida
Weston, Florida, United States
United States, North Carolina
Charlotte, North Carolina, United States
Raliegh, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Washington
Seattle, Washington, United States
Belgium
Brugge, Belgium
Brussels, Belgium
Montegnée, Belgium
Ottignies, Belgium
Sijsele-Damme, Belgium
Bulgaria
Sofia, Bulgaria
Georgia
Tbilisi, Georgia
Greece
Athens, Greece
Thessaloniki, Greece
Hungary
Nyíregyháza, Hungary
Italy
Catania, Italy
Cefalù, Italy
Milano, Italy
Poland
Bialystok, Poland
Czeladz, Poland
Grudziadz, Poland
Katowice, Poland
Kielce, Poland
Konstancin-Jeziorna, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Olsztyn, Poland
Plewiska, Poland
Poznan, Poland
Szczecin, Poland
Warszawa, Poland
Romania
Bucharest, Romania
Campulung, Romania
Cluj-Napoca, Romania
Sibiu, Romania
Timisoara, Romania
Russian Federation
Kazan, Russian Federation
Saransk, Russian Federation
Serbia
Belgrade, Serbia
Kragujevac, Serbia
Nis, Serbia
Spain
Barcelona, Spain
Madrid, Spain
San Sebastián, Spain
Sevilla, Spain
Valencia, Spain
Ukraine
Chernihiv, Ukraine
Dnipropetrovsk, Ukraine
Donetsk, Ukraine
Kharkiv, Ukraine
Kiev, Ukraine
Lutsk, Ukraine
Sponsors and Collaborators
Receptos, Inc.
  More Information

No publications provided

Responsible Party: Receptos, Inc.
ClinicalTrials.gov Identifier: NCT01628393     History of Changes
Other Study ID Numbers: RPC01-201 (Part A), 2012-002714-40
Study First Received: June 22, 2012
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014