Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Completed
Sanofi
Phase 3
2008-02-01
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram
per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of
participants presenting with their first clinical episode consistent with multiple sclerosis
(MS) to clinically definite multiple sclerosis (CDMS).
The secondary objectives were:
- To demonstrate the effect of teriflunomide, in comparison to placebo, on:
- Reducing conversion to definite multiple sclerosis (DMS)
- Reducing annualized relapse rate (ARR)
- Reducing disease activity/progression as measured by Magnetic Resonance Imaging
(MRI)
- Reducing accumulation of disability for at least 12 weeks as measured by the
Expanded Disability Status Scale (EDSS)
- Proportion of disability-free participants as assessed by the EDSS
- Reducing participant-reported fatigue
- To evaluate the safety and tolerability of teriflunomide
- To evaluate the pharmacokinetics (PK) of teriflunomide
- Optional pharmacogenomic testing aimed at assessing the association between the main
enzyme systems of teriflunomide metabolism and hepatic safety, and other potential
associations between gene variations and clinical outcomes
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Completed
Sanofi
Phase 3
2006-10-01
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 document the long-term efficacy on disability progression,
relapse rate and Magnetic Resonance Imaging (MRI) parameters.
Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with
cognition. Currently, there are no FDA-approved treatments targeting cognitive function in
Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used
in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as
compared to treatment with a placebo pill in combination with standard anti-inflammatory
drugs in women with MS.
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