Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
Completed · Phase 4
Conditions studied: Relapsing Forms of Multiple Sclerosis
In brief
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting. The secondary objectives of this study are as follows: * To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting. * To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
Key facts
- Study ID
- NCT01873417
- Run by
- Biogen
- People needed
- 237
- Starts
- 2013-05-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2017-03-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Cullman, Alabama, United States
- Research Site — Gilbert, Arizona, United States
- Research Site — Scottsdale, Arizona, United States
- Research Site — Fullerton, California, United States
- Research Site — Newport Beach, California, United States
- Research Site — Pasadena, California, United States
- Research Site — Englewood, Colorado, United States
- Research Site — Fort Collins, Colorado, United States
- Research Site — Danbury, Connecticut, United States
- Research Site — Maitland, Florida, United States
- Research Site — Naples, Florida, United States
- Research Site — North Palm Beach, Florida, United States
- Research Site — Port Charlotte, Florida, United States
- Research Site — Sarasota, Florida, United States
- Research Site — St. Petersburg, Florida, United States
- Research Site — Tampa, Florida, United States
- Research Site — Tampa, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Milford, Massachusetts, United States
- Research Site — Golden Valley, Minnesota, United States
- Research Site — Patchogue, New York, United States
- Research Site — Charlotte, North Carolina, United States
- Research Site — Greensboro, North Carolina, United States
- Research Site — High Point, North Carolina, United States
Full record on ClinicalTrials.gov
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