Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments ponesimod 10 mg, ponesimod 20 mg, ponesimod 40 mg
Phase phase 2
Sponsor Actelion
Start date May 2010
End date December 2021
Trial size 353 participants
Trial identifier NCT01093326, AC-058B202

Summary

This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ponesimod 10 mg oral use
ponesimod 10 mg
Ponesimod 10 mg oral use
(Experimental)
Ponesimod 20 mg oral use
ponesimod 20 mg
Ponesimod 20 mg oral use
(Experimental)
Ponesimod 40 mg oral use
ponesimod 40 mg
Ponesimod 40 mg oral use

Primary Outcomes

Measure
Annualized confirmed relapse rate
time frame: 240 weeks
Time to first confirmed relapse
time frame: 240 weeks
Time to 3 month confirmed disability progression up to end of the study
time frame: Estimated period of time over which the event is assessed: 3 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression.
Time to 6 month confirmed disability progression up to end of the study
time frame: Estimated period of time over which the event is assessed: 6 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression.

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: 1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201. 2. Signed informed consent for participating in the extension study. Exclusion Criteria: 1. Any 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.

Additional Information

Official title Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Actelion.