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

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

Neuroscience - Multiple Sclerosis, Neuroscience
James Bowen, MD
Caryl Tongco
The purpose of this research study is to evaluate whether montelukast can reduce the severity of gastrointestinal side effects in patients with relapsing forms of Multiple Sclerosis who are taking Tecfidera®. 

Key Inclusion criteria:

  • Age > 18 years at the time of informed consent
  • Reside in the US and have 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.

Key Exclusion criteria:

  • 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 parental, 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.
  • Prior confirmed diagnosis of medical history of chronic eosinophilia.
Caryl Tongco
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