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

Completed · Phase 3 · Has a placebo group

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID
NCT00835770
Run by
Biogen
People needed
1736
Starts
2009-02-03
Expected to finish
2019-11-08
Last updated by the study team
2020-12-31

Who can join

Age: 19 and older, up to 58. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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