Status:
COMPLETED
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to documen...
Detailed Description
Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to continue in the extension study; * participants receiving teriflunomide 7 mg or 14 mg were blindly maintained o...
Eligibility Criteria
Inclusion
- Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
- Willingness to participate in a long-term safety/efficacy trial.
Exclusion
- 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 :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
742 Patients enrolled
Trial Details
Trial ID
NCT00803049
Start Date
October 1 2006
End Date
December 1 2015
Last Update
January 30 2017
Active Locations (116)
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1
Investigational Site Number 1032
Maitland, Florida, United States, 32761
2
Investigational Site Number 1038
Fort Wayne, Indiana, United States, 63104
3
Investigational Site Number 1033
Detroit, Michigan, United States, 48201
4
Investigational Site Number 1037
Allentown, Pennsylvania, United States, 18103