Clinical trial NCT02410278: Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10
timeFrame: Baseline (Day 0), Day 10 (10 days after Day 0)
Secondary outcomes:
measure: Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10
timeFrame: Baseline (Day 0), Day 1 (1 day after Day 0), Day 10 (10 days after Day 0)
measure: Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10
timeFrame: Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)
measure: Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10
timeFrame: Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)
measure: Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8
timeFrame: Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)
measure: Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8
timeFrame: Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)
measure: Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment
timeFrame: Baseline (Day 0), Day 3 (72 hours after Day 0)
measure: Percentage of Participants Who Required GI Symptomatic Therapy During the Study
timeFrame: Day 10 to Week 10
measure: Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10
timeFrame: Day 0 to Week 10
measure: Percentage of Participants Who Experienced AEs Related to Flushing
timeFrame: Day of first DMF dose (up to 27 days before Day 0) to Week 10
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Carmichael
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Pomona
country: United States
facility: Research Site
state: California
city: Simi Valley
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Fairfield
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Naples
country: United States
facility: Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Rome
country: United States
facility: Research Site
state: Georgia
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Flossmoor
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Scarborough
country: United States
facility: Research Site
state: Maine
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Amherst
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Hendersonville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Sanford
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Uniontown
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Tualatin
country: United States
facility: Research Site
state: Oregon
city: Dickson City
country: United States
facility: Research Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Research Site
state: Pennsylvania
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Alexandria
country: United States
facility: Research Site
state: Virginia
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: