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

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.

Timeline

Start

2015-03-12

Primary completion

2017-02-16

Completion

2017-04-27

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority test); MITT-Placebo vs MITT-Montelukast; p = 0.0617; Odds Ratio (OR) 3.931 (95% CI 0.938 to 20.832); weighted logistic regression model NCT02410278 ↗

Drugs

Indications