An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis — TOWER  

Multiple Sclerosis Clinical Trial

Official title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

Status Completed

Clinical Trial Summary

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

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

Other secondary objectives are:

• 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 patient's health on his or her overall well being.

• To evaluate the safety and tolerability of teriflunomide.

Clinical Trial Description

The study consists in:

• A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo is administered in double-blind fashion until a fixed common end date which is approximately 48 weeks after randomization of the last participant.

• An extension treatment period: the highest dose of teriflunomide is administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period is followed by a 4-week elimination follow-up period. ;

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT00751881
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Completion date: August 2015