Tecfidera Slow-Titration Study
Stopped early · Phase 3
Conditions studied: Multiple Sclerosis
In brief
The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.
Key facts
- Study ID
- NCT02428231
- Run by
- Biogen
- People needed
- 62
- Starts
- 2015-04-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-05-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Gilbert, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Long Beach, California, United States
- Research Site — Miami, Florida, United States
- Research Site — Avon, Indiana, United States
- Research Site — Franklin, Indiana, United States
- Research Site — Overland Park, Kansas, United States
- Research Site — Lewiston, Maine, United States
- Research Site — Asheville, North Carolina, United States
- Research Site — Cary, North Carolina, United States
- Research Site — Charlotte, North Carolina, United States
- Research Site — Wilmington, North Carolina, United States
- Research Site — Cincinnati, Ohio, United States
- Research Site — Dallas, Texas, United States
- Research Site — Wenatchee, Washington, United States
- Research Site — Leuven, Belgium
- Research Site — Wilrijk, Belgium
- Research Site — Prague, Czechia
- Research Site — Merano, Bolzano, Italy
- Research Site — Montichiari, Italy
Full record on ClinicalTrials.gov
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