CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,169 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00751881
NCT00751881Phase 3Completed

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

Sanofi·interventional·Posted Sep 12, 2008·Updated Jul 7, 2016

In Brief

A Phase 3 clinical trial evaluating Placebo and Teriflunomide for Multiple Sclerosis. Completed, enrolled 1,169 participants across 193 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belarus, Belgium, Canada, Chile, China, Czechia, Estonia, France, Germany, Greece, Mexico, Netherlands, Philippines, Poland, Romania, Slovakia, Spain, Sweden, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2012
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.8 years ago

Interventions

Placebodrug

Film-coated tablet Oral administration

Teriflunomidedrug

Film-coated tablet Oral administration