RecruitingPhase 1NCT05992311

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI)

Sponsor

Baylor College of Medicine

Enrollment

80 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Gulf War Syndrome

Summary

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.

Eligibility

Min Age: 50 YearsMax Age: 70 Years

Inclusion Criteria13

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:
fatigue/sleep disturbances
neurological/cognitive/mood symptoms
somatic pain
gastrointestinal problems
respiratory symptoms
skin symptoms
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 Criteria30

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

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Interventions

DRUGMontelukast

This group will receive the montelukast treatment.

OTHERPlacebo

This group will receive a placebo pill instead of montelukast

Locations(1)

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

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NCT05992311

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