BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS)

Trial Status
Open for Enrollment

What is the Purpose of this Study?
Previous studies illustrated that patients with relapsing-remitting multiple sclerosis (RRMS) had significantly reduced Gd enhancing lesions on the brain after 6 months of being on BG00012 (dimethl fumarate DMF).

Who is Eligible to Participate?
Patients aged 18-55 with MS who have experienced at least 1 relapse within the last 12 months prior to randomization and who do not meet any exclusionary criteria which will be addressed in further detail by study coordinator.

What is involved in this Study?
This is a placebo controlled, dose-comparison study. Patients will be randomized into a 1:1:1 treatment design. Group 1 will receive oral BG00012, 480 mg daily. Group 2 will receive oral BG00012, 720 mg daily. Group 3 will receive oral placebo. Patients in all three groups will have the option to switch to an approved open-label MS treatment if they have completed at least 48 weeks of treatment and, at any time after 24 weeks, have experienced 1 relapse or experience significant disability progression over the course of the study.

How long is the Study?
The study will be approximately 25 months long.

For More Information Contact: Lynne E. Flynn, CCRC, study coordinator, at 602-258-2863 or lynneflynn@pnal.net or call the Main line at 602-258-3354