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

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

Summary

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Teriflunomide

Criteria

Inclusion Criteria:

• Satisfactorily completion of HMR1726D/2001 study with respect to safety.

• If female subject, non-childbearing potential or child bearing potential with adequate contraception.

• Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.

• Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.

• Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.

• Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.

• Willingness to participate in a long-term safety and efficacy trial.

Exclusion Criteria:

• Subject who did not complete HMR 1726D/2001 study for safety reasons.

• Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.

• Pregnancy.

• Breast-feeding.

• Wish to parent.

• Likelihood of requiring treatment during the study period with drugs not permitted.

• Disallowed therapies such asw immunomodulators, immunosuppressants.

• Recent history of drug or alcohol abuse.

• Liver function impairment.

• Abnormal mental conditions.