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



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:June 29, 2015
End Date:April 27, 2017

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
50
sites
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
?
mi
from
Amherst, NY
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dickson City, Pennsylvania 18519
?
mi
from
Dickson City, PA
Click here to add this to my saved trials
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
?
mi
from
Greensburg, PA
Click here to add this to my saved trials
Hendersonville, North Carolina 28791
?
mi
from
Hendersonville, NC
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
?
mi
from
Pomona, CA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rome, GA
Click here to add this to my saved trials
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Sanford, NC
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Simi Valley, CA
Click here to add this to my saved trials
?
mi
from
Smyrna, GA
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
?
mi
from
Uniontown, OH
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
Wilkes-Barre, Pennsylvania 18711
?
mi
from
Wilkes-Barre, PA
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials