The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
dimethyl fumarate 120 mg capsules
Placebo for BG00012
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)
Time frame: Week 24
Mean number of CUA
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
Mean number of hypointense T1 lesions
Time frame: at 24 weeks
New Gd+ lesions
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
New/enlarging T2 lesions
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
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