Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: dimethyl fumarate; montelukast; Placebo
Intervention description: Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally; As described in the treatment arm; Matched placebo
Intervention MeSH terms: Dimethyl Fumarate; Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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.

        Key Exclusion Criteria:

          -  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

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply