Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide
administered once daily for 24 weeks, compared to placebo, in patients with multiple
sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].
The secondary objectives were:
- to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in
combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,
relapse rate and patient-reported fatigue;
- to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
a stable dose of GA.