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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00134563 |
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 LTS6050 with two doses of Teriflunomide.
Condition | Intervention | Phase |
Multiple Sclerosis |
Drug: teriflunomide (HMR1726) Drug: placebo |
Phase III |
MedlinePlus related topics: | Multiple Sclerosis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), 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 Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses |
Estimated Enrollment: | 1080 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
7 mg
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Drug: teriflunomide (HMR1726)
oral administration once daily
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2: Experimental
14 mg
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Drug: teriflunomide (HMR1726)
oral administration once daily
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3: Placebo Comparator |
Drug: placebo
oral administration once daily
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 21 Study Locations |
Sanofi-Aventis |
Principal Investigator: | Paul O'Connor, MD | St. Michael's Hospital, Toronto |
Related Info 
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Responsible Party: | sanofi-aventis ( ICD ) |
Study ID Numbers: | EFC6049, EudraCT 2004-000555-42, HMR1726D/3001, LTS6050 |
First Received: | August 23, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00134563 |
Health Authority: | Canada: Health Canada; France: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health |
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