Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Pediatrics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 22
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.

Detailed description:

Arms:
arm 1: Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.

Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: None

Protocol document: