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A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 1, 2013
Primary Completion Date
November 1, 2013
Completion Date
November 1, 2013
Last Updated
March 21, 2017
237
ACTUAL participants
BG00012 (DMF)
DRUG
Lead Sponsor
Biogen
NCT06681623
NCT06251986
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04676555