Actively Recruiting
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Led by Baylor College of Medicine · Updated on 2025-08-20
80
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
M
Michael E. DeBakey VA Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study addresses the pre-clinical promise of Montelukast (MLK) for improving brain function in veterans with Gulf War Illness (GWI). MLK, a US Food and Drug administration (FDA)-approved drug for asthma, has shown efficacy in an animal model of GWI to improve cognitive and mood function through modulation of leukotriene signaling and suppression of neuroinflammation.
CONDITIONS
Official Title
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gulf War Veterans of the U.S. military deployed to the Persian Gulf Region between August 2, 1990, and December 31, 1991
- Diagnosed with Gulf War Illness according to CDC and modified Kansas criteria with symptom onset during or after deployment lasting six months or longer in at least 3 of 6 symptom domains: fatigue/sleep disturbances, neurological/cognitive/mood symptoms, somatic pain, gastrointestinal problems, respiratory symptoms, skin symptoms
- Self-reported cognitive dysfunction with a PROMIS v2.0 Cognitive Function 8a short form T-score of 40 or less
- Able to provide written consent and communicate in verbal and written English
- Able to attend two in-person study visits
- Reliable telephone service for eight weekly telephone contacts
You will not qualify if you...
- Diagnosed by a physician with chronic conditions that may explain symptoms or affect reporting, including chronic autoimmune or systemic inflammatory diseases, cancer not in remission for at least 5 years, congestive heart failure, anemia, multiple sclerosis, amyotrophic lateral sclerosis, poorly controlled diabetes, post-chemo or radiation syndromes, sickle cell anemia, symptomatic coronary artery disease, chronic liver disease, chemical insufficiency, morbid obesity (BMI ≥ 40), HIV
- History of alcohol, substance, stimulant, opioid, or other depressant misuse in the past year
- Major mental health conditions interfering with symptom reporting (e.g., psychosis, suicidal ideation, major depressive disorder)
- Hospitalization or invasive procedures in past 12 months for chronic condition exacerbations
- Elevated liver enzymes (2.5 times upper normal limit), low kidney function (eGFR < 60 ml/min/1.73 sqm), or hemoglobin less than 10 g/L at baseline
- Evidence of poorly controlled chronic conditions or others mimicking GWI
- Medication changes for chronic conditions in past 3 months
- Suicidal or homicidal ideation
- Use of Montelukast in past 6 months
- Taking multiple medications with moderate interactions with Montelukast
- Pregnancy or intention to become pregnant
- Active COVID-19 illness without recovery to pre-COVID health status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason K Aguilar, BA
CONTACT
K
Kandice Motley, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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