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An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

NCT00751881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1169

Last updated 2016-07-07

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

Film-coated tablet Oral administration

DRUG

Teriflunomide

Film-coated tablet Oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-04-30
Completion
2015-08-31

Countries

  • United States
  • Australia
  • 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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751881 on ClinicalTrials.gov