Phase 4
Completed N=102
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
Source: ClinicalTrials.gov NCT02410278 ↗Enrolled (actual)
102
Serious AEs
3.7%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10 — 17; 33 percentage of participants — p=0.0617
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10 |
17; 33 | 0.0617 |
| SECONDARY Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10 |
0.80; 0.84; -0.28; -0.23 | 0.3753 |
| SECONDARY Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10 |
0.80; 0.84; -0.37; -0.31 | 0.0376 sig |
| SECONDARY Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10 |
10; 7 | 0.7952 |
| SECONDARY Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8 |
1; 1 | 0.8328 |
| SECONDARY Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8 |
0.80; 0.84; -0.30; -0.21; -0.29; -0.25 | 0.1743 |
| SECONDARY Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment |
0.80; 0.84; -0.28; -0.18 | 0.2469 |
| SECONDARY Percentage of Participants Who Required GI Symptomatic Therapy During the Study |
33; 33 | 1.0000 |
| SECONDARY Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10 |
7; 9 | 1.0000 |
| SECONDARY Percentage of Participants Who Experienced AEs Related to Flushing |
23; 36 | 0.2604 |
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
Data sourced from ClinicalTrials.gov (NCT02410278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.