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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00134563 |
Purpose
The purpose of this study is to determine the effects of teriflunomide on: frequency of relapses; accumulation of disability, measured by Expanded Disability Status Scale (EDSS); burden of disease, measured by magnetic resonance imaging (MRI); subject-reported fatigue; and safety and tolerability.
The 2-years double-blind placebo controlled period is followed by a long term open-label extension study with two doses of Teriflunomide.
| Condition | Intervention | Phase |
|
Multiple Sclerosis |
Drug: teriflunomide |
Phase III |
| MedlinePlus related topics: | Multiple Sclerosis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Physical Disability in Subjects With Multiple Sclerosis Relapses |
Eligibility
| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 18 Study Locations |
| Sanofi-Aventis |
| Principal Investigator: | Paul O'Connor, MD | St. Michael's Hospital, Toronto |
More Information
Related Info 
  |
| Responsible Party: | sanofi-aventis ( ICD ) |
| Study ID Numbers: | EFC6049, LTS6050, HMR1726 |
| First Received: | August 23, 2005 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00134563 |
| Health Authority: | Canada: Health Canada; France: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health |
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