Status:
COMPLETED
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing...
Detailed Description
The study consists of: * A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 4...
Eligibility Criteria
Inclusion
- Relapsing multiple sclerosis,
- Two relapses in prior 2 years or one relapse in prior year.
Exclusion
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
- Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
- Pregnant or nursing woman,
- Alcohol or drug abuse,
- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
- Human immunodeficiency virus (HIV) positive,
- 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 participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
1169 Patients enrolled
Trial Details
Trial ID
NCT00751881
Start Date
August 1 2008
End Date
August 1 2015
Last Update
July 7 2016
Active Locations (193)
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1
Sanofi-Aventis Investigational Site Number 840041
Phoenix, Arizona, United States, 85060
2
Sanofi-Aventis Investigational Site Number 840084
Tucson, Arizona, United States, 85741-3537
3
Sanofi-Aventis Investigational Site Number 840008
Loma Linda, California, United States, 92354
4
Sanofi-Aventis Investigational Site Number 840034
Modesto, California, United States, 95355