NCT01873417

Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 237 (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 (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.

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BG00012 (DMF)

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-06-10
• Last updated: 2017-03-21
• Results posted: 2014-11-11

Locations

37 sites across 1 country: United States