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Montelukast for Gulf War Illness in Veterans

This study is looking at whether montelukast, an FDA-approved asthma medication, can help veterans with Gulf War Illness (GWI). Researchers want to see if montelukast can improve brain function, mood, and thinking skills. They believe montelukast might work by affecting leukotrienes (substances involved in inflammation) and reducing inflammation in the brain. You may be able to join if you are a Gulf War Veteran between 50 and 70 years old, diagnosed with GWI based on specific criteria. The study will measure leukotriene levels at the beginning and after 10 weeks of treatment to see if the medication is having an effect. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 participants. Some participants will receive montelukast, while others will receive a placebo (an inactive pill).
What's involved
Participants will have their leukotriene concentration measured at the start of the study (week 0) and again after 10 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 10 weeks, as leukotriene concentration is measured at week 0 and week 10.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05992311

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

Recruiting
PHASE1Ages 50–70InterventionalTreatment
Baylor College of Medicine
~80 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:MontelukastPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Leukotriene concentration
Measured over taken at baseline (week 0) and after the intervention (week 10)

Conditions

Gulf War Syndrome

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Gulf war syndrome

NCT05992311

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Michael E. DeBakey VA Medical Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Drew A Helmer, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Jason K Aguilar, BA
[email protected]
713-440-4633
Email the study team

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Eligibility criteria

Inclusion

Gulf War Veterans of the U.S. military deployed on military orders to the Persian Gulf Region between August 2, 1990, and December 31, 1991
Diagnosed with GWI according to the CDC and modified Kansas criteria as recommended by the Institute of Medicine (IOM), that is, endorse multiple or moderate-to-severe symptoms, with symptom onset during or after deployment to the Persian Gulf region in 1990-1991, persisting for six months or longer, in at least 3 of 6 domains:
Self-reported cognitive dysfunction based on a T-score of 40 or less on the PROMIS v2.0 Cognitive Function 8a short form
Be able to:
provide written consent and be able to communicate with the research team in verbal and written English
attend the two in-person study encounters
have reliable telephone service for the eight weekly telephone encounters

Exclusion

Diagnosed by a physician with any chronic condition that may explain their profile of symptoms or prevent their ability to accurately report them including:
chronic autoimmune conditions
systemic inflammatory conditions
cancer not in remission at least 5 years
congestive heart failure
anemia
multiple sclerosis
amyotrophic lateral sclerosis (ALS)
poorly controlled diabetes
post-chemo or radiation syndromes
sickle cell anemia
symptomatic Coronary Artery Disease (CAD)
chronic liver disease
chemical insufficiency
morbid obesity (body mass index (BMI) \>= 40)
human immunodeficiency virus (HIV)
alcohol/substance use disorder/stimulant/opioid/other depressant misuse in the past year
major mental health condition (e.g., psychosis, suicidal ideations, major depressive disorder) that interferes with their ability to accurately report symptoms
hospitalized or undergoing invasive procedures in the past 12 months due to exacerbations of any chronic conditions (such as diabetes, coronary artery disease, hypertension, or emphysema)
elevated liver enzymes (2.5 times upper limit of normal) at baseline visit
estimated glomerular filtration rate less than 60 ml/min/1.73 sqm at baseline visit
hemoglobin less than 10 g/L at baseline visit
evidence of poorly controlled chronic conditions listed above, or others that may mimic GWI as per the PI, either by self-report, Veterans Health Administration (VHA) electronic health record information review, laboratory testing or physical examination
Changes in medications for chronic conditions in the 3 months preceding enrollment (based on self-report)
Suicidal ideation based on their responses on the Columbia Suicide Risk Inventory
Prescribed or taking Montelukast in the past 6 months for any reason
Taking 2 or more medications with moderate interactions with Montelukast
Pregnancy or intention to become pregnant
Active homicidal ideation
COVID-19 illness (confirmed or suspected) without recovery to pre-COVID health status

What this trial measures

  • Leukotriene concentrationtaken at baseline (week 0) and after the intervention (week 10)

    Concentrations in the brain-derived extracellular vesicles collected from the circulating peripheral blood.