Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
MITIGATE
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
1 other identifier
interventional
102
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 multiple-sclerosis
Started Mar 2015
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2015
CompletedFirst Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2017
CompletedResults Posted
Study results publicly available
July 24, 2018
CompletedMarch 31, 2020
March 1, 2020
1.9 years
April 2, 2015
April 27, 2018
March 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10
The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Worsening in severity was defined as a positive average change from baseline (Day 0) to Day 10 in the GSRS score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached \>1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Average change is the sum of changes from baseline in GSRS score over the first 10 days divided by the total of days with a GSRS score.
Baseline (Day 0), Day 10 (10 days after Day 0)
Secondary Outcomes (9)
Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10
Baseline (Day 0), Day 1 (1 day after Day 0), Day 10 (10 days after Day 0)
Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10
Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)
Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10
Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)
Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8
Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)
Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8
Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)
- +4 more secondary outcomes
Study Arms (2)
DMF plus montelukast
EXPERIMENTALDMF as described in the United States Prescribing Information (USPI) plus 10mg montelukast tablet once daily according to the prevailing product label (Singulair)
DMF plus placebo
EXPERIMENTALDMF as described in the USPI plus matched placebo
Interventions
Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
Eligibility Criteria
You may qualify if:
- Reside in the United States and have a confirmed diagnosis of a relapsing form of MS and satisfy the therapeutic indication as described in the local label
- As perceived by the Investigator, have the ability to comply with all requirements of the study protocol and to operate the eDiary required to record GI-related events
- Female participants of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 30 days after they complete or withdraw from the study. All men must practice effective contraception, and they should not donate sperm throughout the study and for at least 90 days after their last dose of study treatment.
You may not qualify if:
- History of significant GI disease (for example, irritable bowel disease, peptic ulcer disease, history of major GI surgery, eosinophilic GI disease, or food allergies)
- Chronic use (≥7 consecutive days) of bismuth subsalicylate, simethicone, calcium carbonate, loperamide, proton-pump inhibitors, or ondansetron within 1 month prior to the Screening Visit
- Use of the following medications: montelukast, immunotherapy, mast cell stabilizers, or parenteral, inhaled, or oral steroids up to 1 month prior to the Screening Visit. Use of these medications is also not permitted for the duration of the study (except for the use of montelukast as per study protocol) and will lead to discontinuation
- Have one or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study
- History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (50)
Research Site
Jonesboro, Arkansas, 72401, United States
Research Site
Carmichael, California, 95608, United States
Research Site
La Jolla, California, 92037, United States
Research Site
La Mesa, California, 91942, United States
Research Site
Pomona, California, 91767, United States
Research Site
Simi Valley, California, 93065, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Fairfield, Connecticut, 06824, United States
Research Site
Washington D.C., District of Columbia, 20057, United States
Research Site
Jacksonville, Florida, 32216, United States
Research Site
Naples, Florida, 34102, United States
Research Site
Ormond Beach, Florida, 32174-3102, United States
Research Site
Sunrise, Florida, 33351, United States
Research Site
Rome, Georgia, 30165-1625, United States
Research Site
Smyrna, Georgia, 30269, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Flossmoor, Illinois, 60422, United States
Research Site
Indianapolis, Indiana, 46256, United States
Research Site
Louisville, Kentucky, 40207, United States
Research Site
Scarborough, Maine, 04074, United States
Research Site
Farmington Hills, Michigan, 48334, United States
Research Site
Chesterfield, Missouri, 63017, United States
Research Site
Kansas City, Missouri, 64111, United States
Research Site
St Louis, Missouri, 63104, United States
Research Site
Freehold, New Jersey, 07728, United States
Research Site
Amherst, New York, 14226, United States
Research Site
New York, New York, 10029, United States
Research Site
Patchogue, New York, 11772, United States
Research Site
Hendersonville, North Carolina, 28792, United States
Research Site
Raleigh, North Carolina, 27607-6010, United States
Research Site
Sanford, North Carolina, 27330, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Dayton, Ohio, 45417, United States
Research Site
Dayton, Ohio, 45459, United States
Research Site
Uniontown, Ohio, 44685, United States
Research Site
Oklahoma City, Oklahoma, 73109, United States
Research Site
Portland, Oregon, 97225, United States
Research Site
Tualatin, Oregon, 97062, United States
Research Site
Dickson City, Pennsylvania, 18519, United States
Research Site
Greensburg, Pennsylvania, 15601, United States
Research Site
Hershey, Pennsylvania, 17033, United States
Research Site
Wilkes-Barre, Pennsylvania, 18711, United States
Research Site
Nashville, Tennessee, 37215, United States
Research Site
Dallas, Texas, 75214, United States
Research Site
Round Rock, Texas, 78681, United States
Research Site
Alexandria, Virginia, 22310, United States
Research Site
Newport News, Virginia, 23601, United States
Research Site
Seattle, Washington, 98122, United States
Research Site
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
March 12, 2015
Primary Completion
February 16, 2017
Study Completion
April 27, 2017
Last Updated
March 31, 2020
Results First Posted
July 24, 2018
Record last verified: 2020-03