drugset / Trial / NCT02125604

Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

NCT02125604

Phase 4 Completed 214 enrolled Biogen
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting. The secondary objectives of this study in this study population are as follows: to evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; to evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.

Timeline

Start
2014-06
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject dimethyl fumarate Unknown 240 mg Oral