Teriflunomide Phase III news

dignan · Family Elder Joined: Aug 12, 2004 Posts: 1191

I've been wondering when there would be more information about the teriflunomide trials in North America. I guess it takes a lot of work to get a phase III study up and running.

Phase III Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients with Multiple Sclerosis

This study is not yet open for patient recruitment.

Sponsored by: Aventis Pharmaceuticals

Purpose
Multinational Study; 2 years treatment duration; objectives are to determine the effects of teriflunomide on: frequency of relapses; accumulation of disability as measured by EDSS; burden of disease as measured by MRI, subject-reported fatigue; and safety and tolerability

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Physical Disability in Subjects with Multiple Sclerosis Relapses
Further Study Details:

Expected Total Enrollment: 870

Study start: September 2004

Eligibility
Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both
Criteria

Inclusion Criteria:
* Eligible subjects must be exhibiting a relapsing course with or without progression
* Must meet McDonald's criteria for MS diagnosis
* Have experienced at least 2 relapses in the last 2 years

Exclusion Criteria:
* Relapse onset in last 60 days
* significant impaired bone marrow function
* anemia, leukopenia or thrombocytopenia

Last Updated: August 24, 2005
Record first received: August 23, 2005

http://www.clinicaltrials.gov/ct/show/NCT00134563?order=30