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

Multiple Sclerosis Clinical Trial

Official title:
A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Clinical Trial 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.

Clinical Trial Description

The total duration of the study period per participants was 46 weeks comprising 3 periods:

- a 4-week screening period,

- a 36-week double-blind treatment period,

- a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01487096
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date April 2001
Completion date March 2003
View Details
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