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Leukotriene Modulator

Montelukast for Gulf War Syndrome ((GWI) Trial)

Phase 1
Waitlist Available
Led By Drew A Helmer, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
attend the two in-person study encounters
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up taken at baseline (week 0) and after the intervention (week 10)

Summary

This trial investigates the potential benefits of using Montelukast (MLK), an FDA-approved drug for asthma, to improve brain function in veterans with Gulf War Illness (GWI). Studies in

Who is the study for?
This trial is for U.S. Gulf War veterans who served between August 2, 1990, and December 31, 1991, and are experiencing symptoms like somatic pain, fatigue or sleep issues, respiratory or skin conditions, cognitive dysfunction with a specific test score threshold, mood disturbances or gastrointestinal problems. Participants must be able to communicate in English and attend two in-person study visits.
What is being tested?
The trial is testing Montelukast (MLK), an FDA-approved asthma drug that may improve brain function by reducing inflammation. It's being compared to a placebo to see if it can help with cognitive and mood issues in veterans with Gulf War Illness.
What are the potential side effects?
Montelukast side effects might include abdominal pain, headache, thirstiness; however the exact side effects experienced by participants will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can attend the two required in-person study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~taken at baseline (week 0) and after the intervention (week 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and taken at baseline (week 0) and after the intervention (week 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Leukotriene concentration
Secondary study objectives
Change in RCAT (Halstead Category Test-Russell Revised Version)
Change in Veterans Rand-36 Physical Component Summary (VR-36 PCS) score

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Montelukast GroupExperimental Treatment1 Intervention
Montelukast two capsules of 20 mg (40 mg total) taken by mouth once daily for ten weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Microcrystalline cellulose two capsules taken by mouth once daily for ten weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,430 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
66 Previous Clinical Trials
17,151 Total Patients Enrolled
Texas A&M UniversityOTHER
147 Previous Clinical Trials
23,372 Total Patients Enrolled
~53 spots leftby Jan 2027
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