Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: (T,G)-A-L; Dimethyl Fumarate; Glatiramer Acetate

Criteria

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

• Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4

• Must have a baseline EDSS between 0.0 and 5.0, inclusive.

• Must have relapsing-remitting disease course.

Key Exclusion Criteria:

• Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease

• Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.