Recruiting
Phase 1

Montelukast

Sponsor:

Baylor College of Medicine

Code:

NCT05992311

Conditions

Gulf War Syndrome

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Interventions

Montelukast

Placebo

Study Details

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.

Conditions

Gulf War Syndrome

Study ID

NCT05992311

Start date

Aug 15, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Montelukast Group

Montelukast two capsules of 20 mg (40 mg total) taken by mouth once daily for ten weeks

placebo comparator: Placebo Group

Microcrystalline cellulose two capsules taken by mouth once daily for ten weeks

Interventions

Montelukast

This group will receive the montelukast treatment.

Placebo

This group will receive a placebo pill instead of montelukast

Primary outcome measure

  • Leukotriene concentration [ Time Frame: taken at baseline (week 0) and after the intervention (week 10) ]

Central Contacts and Locations

Central contacts

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Montelukast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-09-01.