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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT02410278

Public ClinicalTrials.gov record NCT02410278. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 1:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02410278
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Biogen
Industry
Enrollment
102 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 12, 2015 (Actual)
Primary completion
Feb 16, 2017 (Actual)
Completion
Apr 27, 2017 (Actual)
Last update posted
Mar 31, 2020

2015 – 2017

United States locations

U.S. sites
50
U.S. states
25
U.S. cities
49
Facility City State ZIP Site status
Research Site Jonesboro Arkansas 72401 —
Research Site Carmichael California 95608 —
Research Site La Jolla California 92037 —
Research Site La Mesa California 91942 —
Research Site Pomona California 91767 —
Research Site Simi Valley California 93065 —
Research Site Aurora Colorado 80045 —
Research Site Colorado Springs Colorado 80907 —
Research Site Fairfield Connecticut 06824 —
Research Site Washington D.C. District of Columbia 20057 —
Research Site Jacksonville Florida 32216 —
Research Site Naples Florida 34102 —
Research Site Ormond Beach Florida 32174-3102 —
Research Site Sunrise Florida 33351 —
Research Site Rome Georgia 30165-1625 —
Research Site Smyrna Georgia 30269 —
Research Site Chicago Illinois 60612 —
Research Site Flossmoor Illinois 60422 —
Research Site Indianapolis Indiana 46256 —
Research Site Louisville Kentucky 40207 —
Research Site Scarborough Maine 04074 —
Research Site Farmington Hills Michigan 48334 —
Research Site Chesterfield Missouri 63017 —
Research Site Kansas City Missouri 64111 —
Research Site St Louis Missouri 63104 —
Research Site Freehold New Jersey 07728 —
Research Site Amherst New York 14226 —
Research Site New York New York 10029 —
Research Site Patchogue New York 11772 —
Research Site Hendersonville North Carolina 28792 —
Research Site Raleigh North Carolina 27607-6010 —
Research Site Sanford North Carolina 27330 —
Research Site Winston-Salem North Carolina 27103 —
Research Site Dayton Ohio 45417 —
Research Site Dayton Ohio 45459 —
Research Site Uniontown Ohio 44685 —
Research Site Oklahoma City Oklahoma 73109 —
Research Site Portland Oregon 97225 —
Research Site Tualatin Oregon 97062 —
Research Site Dickson City Pennsylvania 18519 —
Research Site Greensburg Pennsylvania 15601 —
Research Site Hershey Pennsylvania 17033 —
Research Site Wilkes-Barre Pennsylvania 18711 —
Research Site Nashville Tennessee 37215 —
Research Site Dallas Texas 75214 —
Research Site Round Rock Texas 78681 —
Research Site Alexandria Virginia 22310 —
Research Site Newport News Virginia 23601 —
Research Site Seattle Washington 98122 —
Research Site Madison Wisconsin 53705 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02410278, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 31, 2020 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02410278 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →