NCT01156311

BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).

Conditions

• Relapsing-Remitting Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-07-02
• Last updated: 2017-03-21
• Results posted: 2015-06-09

Locations

16 sites across 1 country: United States