Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: Michael E. DeBakey VA Medical Center; Texas A&M University
• Treatments: Montelukast

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