Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
NCT ID: NCT01873417
Last Updated: 2017-03-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
237 participants
INTERVENTIONAL
2013-05-31
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tecfidera and the Gut Microbiota
NCT02471560
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
NCT02410278
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
NCT01903291
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
NCT02125604
Dimethyl Fumarate (DMF) Observational Study
NCT02047097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dimethyl Fumarate
120 mg DMF twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants will be instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
BG00012 (DMF)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BG00012 (DMF)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Naïve to DMF or fumaric acid esters.
* Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
* Satisfies the approved therapeutic indication(s) for DMF.
Exclusion Criteria
* History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
* Is participating in any other interventional clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Research Site
Fargo, North Dakota, United States
Research Site
Portland, Oregon, United States
Research Site
Monroeville, Pennsylvania, United States
Research Site
Cordova, Tennessee, United States
Research Site
Franklin, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Round Rock, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Richmond, Virginia, United States
Research Site
Roanoke, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fox EJ, Vasquez A, Grainger W, Ma TS, von Hehn C, Walsh J, Li J, Zambrano J. Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a Multicenter, Open-Label Study of Patients with Relapsing Forms of Multiple Sclerosis (MANAGE). Int J MS Care. 2016 Jan-Feb;18(1):9-18. doi: 10.7224/1537-2073.2014-101.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
109MS403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.