NCT00835770

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,736 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 19 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

Detailed description

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	BG00012 capsules
DRUG	Placebo	Capsules taken to maintain the blind in the 240 mg BID treatment group.

Timeline

• Start date: 2009-02-03
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2009-02-04
• Last updated: 2020-12-31
• Results posted: 2020-12-31

Locations

246 sites across 34 countries: United States, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Mexico, Moldova, Netherlands, New Zealand, North Macedonia, Poland, Puerto Rico, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom