Study of Montelukast on Gastrointestinal Tolerability in Patients With
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
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10 | Odds Ratio (OR) 3.931 | 0.938–20.832 | 0.0617 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Montelukast
Placebo
- Placebo
Results by group
Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10
Baseline (Day 0), Day 10 (10 days after Day 0)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MITT-Placebo | 17 percentage of participants | 30 | |
| MITT-Montelukast | 33 percentage of participants | 33 |
MITT-Placebo
MITT-Montelukast
p = 0.0617; Odds Ratio (OR) 3.931 (95% CI 0.938–20.832)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| DMF Safety Population | 98 | 3 (3.1%) | 0 |
| Primary Safety Population-Placebo | 31 | 2 (6.5%) | 0 |
| Primary Safety Population-Montelukast | 33 | 1 (3.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10
Baseline (Day 0), Day 10 (10 days after Day 0)
Safety
Other measures (9)
Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10
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
Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)
Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10
Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)
Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8
Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)
Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8
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
Baseline (Day 0), Day 3 (72 hours after Day 0)
Percentage of Participants Who Required GI Symptomatic Therapy During the Study
Day 10 to Week 10
Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10
Day 0 to Week 10
PainSafetyPercentage of Participants Who Experienced AEs Related to Flushing
Day of first DMF dose (up to 27 days before Day 0) to Week 10
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Mar 2015
Main results due
Feb 2017
Finished
Apr 2017
Results posted
Jul 2018