Status:
COMPLETED
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses. Secondary objectives were: * To determine the effect of terifl...
Detailed Description
The total duration of the study period per participants was 46 weeks comprising 3 periods: * a 4-week screening period, * a 36-week double-blind treatment period, * a 6-week post-treatment follow-up ...
Eligibility Criteria
Inclusion
- Clinically confirmed multiple sclerosis \[MS\];
- Expanded Disability Status Scale \[EDSS\] score less or equal to 6;
- Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
- Screening magnetic resonance imaging \[MRI\] scan fulfilling the criteria for a diagnosis of MS.
Exclusion
- Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
- Pregnant or nursing woman;
- Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
- Prior treatment with interferon \[IFN\], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01487096
Start Date
April 1 2001
End Date
March 1 2003
Last Update
October 4 2012
Active Locations (2)
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1
Canada
Toronto, Ontario, Canada
2
sanofi-aventis France
Lyon, France