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
- Research Site — Huntsville, Alabama, United States
- research Site — Mesa, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Loma Linda, California, United States
- Research Site — Boulder, Colorado, United States
- Research Site — Fort Collins, Colorado, United States
- Research Site — North Haven, Connecticut, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Maitland, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Naples, Florida, United States
- Research Site — Sarasota, Florida, United States
- Research Site — Tampa, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Evanston, Illinois, United States
- Research Site — Fort Wayne, Indiana, United States
- Research Site — Kansas City, Kansas, United States
- Research Site — Wichita, Kansas, United States
- Research Site — Shreveport, Louisiana, United States
- Research Site — Baltimore, Maryland, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Farmington Hills, Michigan, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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