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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 LTS6050 with two doses of Teriflunomide.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: teriflunomide (HMR1726) Drug: placebo |
Phase III |
| 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
|
Drug: teriflunomide (HMR1726)
oral administration once daily
|
|
2: Experimental
14 mg
|
Drug: teriflunomide (HMR1726)
oral administration once daily
|
| 3: Placebo Comparator |
Drug: placebo
oral administration once daily
|
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 21 Study Locations| Principal Investigator: | Paul O'Connor, MD | St. Michael's Hospital, Toronto |
More Information
| Responsible Party: | sanofi-aventis ( ICD ) |
| Study ID Numbers: | EFC6049, EudraCT 2004-000555-42, HMR1726D/3001, LTS6050 |
| Study First Received: | August 23, 2005 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00134563 History of Changes |
| Health Authority: | Canada: Health Canada; France: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health |
|
Multiple Sclerosis Relapsing Remitting Secondary Progressive Progressive Relapsing |
|
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Neoplasm Metastasis |
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 |