Status:
COMPLETED
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
Lead Sponsor:
Biogen
Conditions:
Relapsing Forms of Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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) ...
Eligibility Criteria
Inclusion
- Key
- Decision to treat with DMF must precede enrollment.
- 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.
- Key
Exclusion
- Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
- History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
- Is participating in any other interventional clinical trial.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01873417
Start Date
May 1 2013
End Date
November 1 2013
Last Update
March 21 2017
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Cullman, Alabama, United States, 35058
2
Research Site
Gilbert, Arizona, United States, 85234
3
Research Site
Scottsdale, Arizona, United States, 85258
4
Research Site
Fullerton, California, United States, 92835