RECRUITING

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

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Conditions

Gulf War SyndromeMontelukast

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI)

Quick Facts

Study Start:2025-08-15
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05992311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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:
  3. 1. fatigue/sleep disturbances
  4. 2. neurological/cognitive/mood symptoms
  5. 3. somatic pain
  6. 4. gastrointestinal problems
  7. 5. respiratory symptoms
  8. 6. skin symptoms
  9. * Self-reported cognitive dysfunction based on a T-score of 40 or less on the PROMIS v2.0 Cognitive Function 8a short form
  10. * Be able to:
  11. * provide written consent and be able to communicate with the research team in verbal and written English
  12. * attend the two in-person study encounters
  13. * have reliable telephone service for the eight weekly telephone encounters
  1. * Diagnosed by a physician with any chronic condition that may explain their profile of symptoms or prevent their ability to accurately report them including:
  2. * chronic autoimmune conditions
  3. * systemic inflammatory conditions
  4. * cancer not in remission at least 5 years
  5. * congestive heart failure
  6. * anemia
  7. * multiple sclerosis
  8. * amyotrophic lateral sclerosis (ALS)
  9. * poorly controlled diabetes
  10. * post-chemo or radiation syndromes
  11. * sickle cell anemia
  12. * symptomatic Coronary Artery Disease (CAD)
  13. * chronic liver disease
  14. * chemical insufficiency
  15. * morbid obesity (body mass index (BMI) \>= 40)
  16. * human immunodeficiency virus (HIV)
  17. * alcohol/substance use disorder/stimulant/opioid/other depressant misuse in the past year
  18. * major mental health condition (e.g., psychosis, suicidal ideations, major depressive disorder) that interferes with their ability to accurately report symptoms
  19. * 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)
  20. * elevated liver enzymes (2.5 times upper limit of normal) at baseline visit
  21. * estimated glomerular filtration rate less than 60 ml/min/1.73 sqm at baseline visit
  22. * hemoglobin less than 10 g/L at baseline visit
  23. * 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
  24. * Changes in medications for chronic conditions in the 3 months preceding enrollment (based on self-report)
  25. * Suicidal ideation based on their responses on the Columbia Suicide Risk Inventory
  26. * Prescribed or taking Montelukast in the past 6 months for any reason
  27. * Taking 2 or more medications with moderate interactions with Montelukast
  28. * Pregnancy or intention to become pregnant
  29. * Active homicidal ideation
  30. * COVID-19 illness (confirmed or suspected) without recovery to pre-COVID health status

Contacts and Locations

Study Contact

Jason K Aguilar, BA
CONTACT
713-440-4633
jason.aguilar@va.gov
Kandice Motley, BS
CONTACT
713-440-4445
kandice.motley@bcm.edu

Principal Investigator

Drew A Helmer, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Drew A Helmer, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Montelukast

Additional Relevant MeSH Terms

  • Gulf War Syndrome