A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis

Title
A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis

Type of intervention
Drug

Form of MS
Relapsing-remitting

Brief summary
This is a phase III, multi-center, placebo controlled clinical research study evaluating the safety and efficacy of an oral investigational medication for the treatment of patients with relapsing multiple sclerosis (RMS). The study will examine the effect of oral investigational medication on frequency of MS relapses in patients with RMS. During the course of the study, participants will be randomized to the investigational medication or placebo in a ratio of 2:1. The treatment duration is 48 weeks for the last patient recruited. The treatment period will have a fixed end for all patients who will have the last treatment visit after the EOT (48 weeks) for the last patient randomized. For those patients who complete the treatment period, a long term extension study will be proposed.

Inclusion criteria
Patients with relapsing forms of multiple sclerosis meeting McDonald's criteria for MS diagnosis at time of screening visit, and EDSS score =5.5 at screening visit. At least one relapse in the 12 months preceding randomization, or at least 2 relapses in the 24 months preceding the randomization visit

Anticipated start date

Recruitment status
study ongoing, no longer recruiting

Recruitment contacts

Further details
http://www.clinicaltrials.gov/ct2/show/study/NCT00751881?term=Teriflunomide&rank=6&show_locs=Y#locn

Region
SA, NSW, VIC

Trial results

Last updated: May 2011