Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: relapsing multiple sclerosis oral remitting
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1417
Healthy volunteers: no

Brief summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Detailed description:
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Arms:
arm 1: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) arm 2: Participants received two 120 mg BG00012 capsules orally three times daily (TID) arm 3: Participants received two placebo capsules orally three times daily (TID) arm 4: Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Interventions: intervention 1: BG00012 intervention 2: Placebo intervention 3: Glatiramer Acetate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: