An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

• To assess the effect of the two doses of teriflunomide in comparison to placebo on:

• Fatigue;

• Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.

• To evaluate the safety and tolerability of teriflunomide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Teriflunomide

Criteria

Inclusion Criteria:

• Relapsing multiple sclerosis,

• Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,

• Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,

• Pregnant or nursing woman,

• Alcohol or drug abuse,

• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,

• Human immunodeficiency virus (HIV) positive,

• Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.