Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02410278
• Date of registration: 02/04/2015
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera MITIGATE
• Scientific title: 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
• Date of first enrolment: March 12, 2015
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02410278
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: montelukast

Drug: Placebo

Drug: dimethyl fumarate

Primary Outcome(s)

Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10 [Time Frame: Baseline (Day 0), Day 10 (10 days after Day 0)]

Secondary Outcome(s)

Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8 [Time Frame: Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)]

Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment [Time Frame: Baseline (Day 0), Day 3 (72 hours after Day 0)]

Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8 [Time Frame: Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)]

Percentage of Participants Who Experienced AEs Related to Flushing [Time Frame: Day of first DMF dose (up to 27 days before Day 0) to Week 10]

Percentage of Participants Who Required GI Symptomatic Therapy During the Study [Time Frame: Day 10 to Week 10]

Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10 [Time Frame: Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)]

Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10 [Time Frame: 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 [Time Frame: Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)]

Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10 [Time Frame: Day 0 to Week 10]

Secondary ID(s)

109MS414

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02410278