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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00622700 |
The primary objective is to demonstrate the effect of teriflunomide (14 mg/day and 7 mg/day) compared to placebo for reducing conversion of patients presenting with their first clinical episode consistent with Multiple Sclerosis (MS) to clinically definite MS.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Teriflunomide (HMR1726) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis |
Estimated Enrollment: | 780 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
dose 7 mg
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Drug: Teriflunomide (HMR1726)
oral administration once daily
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2: Experimental
dose 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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6260, HMR1726D-3005, EudraCT 2006-001152-12 |
Study First Received: | February 14, 2008 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00622700 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut |
MS CIS CDMS relapses |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |