Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
NCT ID: NCT02410278
Last Updated: 2020-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2015-03-12
2017-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DMF plus montelukast
DMF as described in the United States Prescribing Information (USPI) plus 10mg montelukast tablet once daily according to the prevailing product label (Singulair)
dimethyl fumarate
Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
montelukast
As described in the treatment arm
DMF plus placebo
DMF as described in the USPI plus matched placebo
dimethyl fumarate
Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
Placebo
Matched placebo
Interventions
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dimethyl fumarate
Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
montelukast
As described in the treatment arm
Placebo
Matched placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Jonesboro, Arkansas, United States
Research Site
Carmichael, California, United States
Research Site
La Jolla, California, United States
Research Site
La Mesa, California, United States
Research Site
Pomona, California, United States
Research Site
Simi Valley, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Naples, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Sunrise, Florida, United States
Research Site
Rome, Georgia, United States
Research Site
Smyrna, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Flossmoor, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Louisville, Kentucky, United States
Research Site
Scarborough, Maine, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Chesterfield, Missouri, United States
Research Site
Kansas City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Freehold, New Jersey, United States
Research Site
Amherst, New York, United States
Research Site
New York, New York, United States
Research Site
Patchogue, New York, United States
Research Site
Hendersonville, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Sanford, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Dayton, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Uniontown, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Tualatin, Oregon, United States
Research Site
Dickson City, Pennsylvania, United States
Research Site
Greensburg, Pennsylvania, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Wilkes-Barre, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Round Rock, Texas, United States
Research Site
Alexandria, Virginia, United States
Research Site
Newport News, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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109MS414
Identifier Type: -
Identifier Source: org_study_id
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