NCT05992311 Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
| NCT ID | NCT05992311 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Baylor College of Medicine |
| Condition | Gulf War Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-08-15 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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: 1. fatigue/sleep disturbances 2. neurological/cognitive/mood symptoms 3. somatic pain 4. gastrointestinal problems 5. respiratory symptoms 6. 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 * 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
Contact & Investigator
Drew A Helmer, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT05992311 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 70 Years, studying Gulf War Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05992311 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05992311 currently recruiting?
Yes, NCT05992311 is actively recruiting participants. Contact the research team at jason.aguilar@va.gov for enrollment information.
Where is the NCT05992311 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05992311 clinical trial?
NCT05992311 is sponsored by Baylor College of Medicine. The principal investigator is Drew A Helmer, MD at Baylor College of Medicine. The trial plans to enroll 80 participants.