Status:
RECRUITING
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
Texas A&M University
Conditions:
Gulf War Syndrome
Eligibility:
All Genders
50-70 years
Phase:
PHASE1
Brief 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 a...
Detailed Description
Background: Approximately 30% of Gulf War Veterans (1990-1991) suffer from Gulf War Illness (GWI), a chronic condition characterized by disabling symptoms in multiple domains. Animal models and human ...
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:
- 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
- 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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05992311
Start Date
August 15 2025
End Date
August 1 2028
Last Update
August 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030