Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients

This study is currently recruiting participants.

Verified April 2013 by Receptos, Inc.

Sponsor:

Information provided by (Responsible Party):

Receptos, Inc.

ClinicalTrials.gov Identifier:

NCT01628393

First received: June 22, 2012

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2012

Last Updated Date

April 11, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01628393 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Relapsing Multiple Sclerosis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: RPC1063 Low Dose
Intervention: Drug: RPC1063
Placebo Comparator: placebo
Intervention: Drug: placebo
Experimental: RPC1063 High Dose
Intervention: Drug: RPC1063

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Completion Date

Not Provided

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mike Andino

+1 855-714-0086

Mike.Andino@ppdi.com

Location Countries ^ICMJE

United States, Georgia, Poland

Administrative Information

NCT Number ^ICMJE

NCT01628393

Other Study ID Numbers ^ICMJE

RPC01-201

Has Data Monitoring Committee

Yes

Responsible Party

Receptos, Inc.

Study Sponsor ^ICMJE

Receptos, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Receptos, Inc.

Verification Date

April 2013

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

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