NCT02283853

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	administered orally
DRUG	Interferon β-1a	administered by intramuscular injection

Timeline

• Start date: 2014-08-28
• Primary completion: 2025-07-08
• Completion: 2025-07-08
• First posted: 2014-11-05
• Last updated: 2025-07-20

Locations

62 sites across 18 countries: United States, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Kuwait, Poland, Serbia, Spain, Sweden, Turkey (Türkiye), United Kingdom