At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
dimethyl fumaratedrug
Likely dose
dimethyl fumarate 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating dimethyl fumarate for Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis. Completed, enrolled 108 participants across 16 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJul 2010
Primary CompletionMar 2012
TodayJul 2026
First PostedJul 2, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16 years ago
Interventions
dimethyl fumaratedrug
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.