NCT02125604

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

A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	capsules administered according to the prevailing product label

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2014-04-29
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

19 sites across 1 country: Germany