Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
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