Multicenter, randomized, double-blind, parallel-group extension to study AC-058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ACT-128800, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis.

• Conditions: Relapsing-remitting multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2009-011470-15-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study. 2. Women of childbearing potential must have a negative urine pregnancy test at their regular Week 24 visit within the core study and agree to continue using two methods of contraception as required for the core study until 8 weeks after study drug discontinuation. 3. Signed informed consent for participating in the extension study prior to administration of the first dose in the transition period (i.e., prior to continuation of dosing at Visit 11 (Week 24) of the core study).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients meeting at their regular Week 24 (EOT) visit, during the transition period, and/or at Visit E1 any of the study-specific criteria for permanent discontinuation of study drug as defined in Appendix 1, or patients receiving any of the prohibited concomitant medication as outlined in Section 3.3.4.3 and Appendix 8. 2. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified