NCT02428218

Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	enteric-coated microtablets
DRUG	Placebo	enteric-coated microtablets

Timeline

• Start date: 2016-05-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2015-04-28
• Last updated: 2016-04-13