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An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis - NCT00751881-05201(Clinical Trial 382083)



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City:  Bennington
State:  
VT
Zip Code: 05201
Conditions: Multiple Sclerosis
Purpose: The objective of the study is to evaluate the effect of two doses of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis. The effect on worsening of disability, fatigue and safety will also be evaluated.
Study summary: The study period per patient is expected to be between 68 and 174 weeks depending on when the patient is randomized and broken as follows: - a screening period up to 4 weeks, - a treatment period expected to be between 48 and 154 weeks, - 16-week post washout follow-up period. Patients will continue on treatment until a fixed common end date which will be approximately 48 weeks after randomization of the last patient. For those patients who complete the treatment period, a long term extension study will be proposed.
Criteria: Inclusion Criteria: - Relapsing multiple sclerosis - Two relapses in prior 2 years or one relapse in prior year Exclusion Criteria: - Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease - Patients with significantly impaired bone marrow function - Pregnant or nursing women - Alcohol or drug abuse - Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment - Human immunodeficiency virus (HIV) positive patients - Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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