Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

• To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.

• To investigate the pharmacokinetic and pharmacodynamic relationships.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Teriflunomide

Criteria

Inclusion Criteria:

• Clinically confirmed multiple sclerosis [MS];

• Expanded Disability Status Scale [EDSS] score less or equal to 6;

• Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;

• Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.

Exclusion Criteria:

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

• Pregnant or nursing woman;

• Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);

• Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;

• Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;

• 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 patient's potential participation in a clinical trial.