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
    Recruiting
  • sponsor
    Biogen Idec MA Inc.
Updated on 8 November 2020

Summary

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

Description

The primary objective of this study is to evaluate whether montelukast can reduce the severity of GI events after oral administration of DMF in subjects with relapsing forms of MS.

Details
Clinical Study IdentifierTX143326
SponsorBiogen Idec MA Inc.
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

a GSRS score of ≥5 in 1 question for 1 day, a GSRS score of ≥4 in 1 question for 2 consecutive days, or a GSRS score of ≥3 in 1 question for 3 consecutive days
Subjects who did not meet the required eDiary compliance (≥75%) in the 14 days prior to randomization

Exclusion Criteria

Inability to comply with the study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation
Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant during the study
History of significant GI disease (e.g., 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. From Screening up to Day 10, use of such therapies is not permitted. From Day 11 (inclusive), subjects are permitted to take these therapies
Use of anti-allergy medications such as montelukast, immunotherapy, antihistamines, 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 and will lead to discontinuation
Treatment with montelukast is contraindicated for any reason
Exposure to fumarates in the 3 months prior to the Screening Visit. Exposure is also not permitted for the duration of the Screening Period
Have 1 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
Prior confirmed diagnosis or medical history of chronic eosinophilia
Current enrollment in any other interventional clinical studies
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