NCT05992311 · Baylor College of Medicine
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
((GWI))
What this study 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 effectiveness in an animal model of GWI to improve cognitive and mood function through modulation of leukotriene signaling and suppression of neuroinflammation.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2025 · Source of record for eligibility and locations