The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
enteric-coated microtablets
enteric-coated microtablets
Time to first multiple sclerosis (MS) relapse
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Time frame: Up to week 104
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to week 104
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans
Time frame: Weeks 24, 48, 72 and 96
Number of gadolinium-enhancing Lesions
Time frame: Baseline, and weeks 24, 48, 72 and 96
Annualized MS relapse rate
Time frame: weeks 48 and 96
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