CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,736 enrolled
Drug / intervention
dimethyl fumarate +1 moredrug
Likely dose
Placebo 240 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.

Search/NCT00835770
NCT00835770Phase 3Completed
CompareCT.gov

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

Biogen·interventional·Posted Feb 4, 2009·Updated Dec 31, 2020

In Brief

A Phase 3 clinical trial evaluating dimethyl fumarate and Placebo for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 1,736 participants across 246 sites in 34 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2009
Enrollment StartFeb 3, 2009
Primary CompletionNov 8, 2019
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 17.4 years ago

Interventions

dimethyl fumaratedrug

BG00012 capsules

Placebodrug

Capsules taken to maintain the blind in the 240 mg BID treatment group.