NCT02410278

Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on 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: 102 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as follows: To evaluate whether montelukast after oral administration of DMF in participants with relapsing forms of MS decreases discontinuations due to GI events and reduces the number of participants taking symptomatic therapies for GI events; To investigate the effect of montelukast on the incidence of flushing events after oral administration of 240 mg DMF in participants with relapsing forms of MS.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
DRUG	montelukast	As described in the treatment arm
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2015-03-12
• Primary completion: 2017-02-16
• Completion: 2017-04-27
• First posted: 2015-04-07
• Last updated: 2020-03-31
• Results posted: 2018-07-24

Locations

50 sites across 1 country: United States