Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

NCT05992311 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: H-51973CDMRP-GW210062
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Montelukast

Outcome Measures

Primary Outcomes (1)

• Leukotriene concentration

  Concentrations in the brain-derived extracellular vesicles collected from the circulating peripheral blood.

  taken at baseline (week 0) and after the intervention (week 10)

Secondary Outcomes (2)

• Change in RCAT (Halstead Category Test-Russell Revised Version)

  taken at baseline (week 0) and after the intervention (week 10)

• Change in Veterans Rand-36 Physical Component Summary (VR-36 PCS) score

  taken at baseline (week 0) and after the intervention (week 10)

Study Arms (2)

Montelukast Group

EXPERIMENTAL

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

Drug: Montelukast

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Montelukast DRUG

This group will receive the montelukast treatment.

Also known as: Singulair

Montelukast Group

Placebo OTHER

This group will receive a placebo pill instead of montelukast

Placebo Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator
• Texas A&M University: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

montelukast

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Study Officials

• Drew A Helmer, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason K Aguilar, BA

CONTACT

713-440-4633; jason.aguilar@va.gov

Kandice Motley, BS

CONTACT

713-440-4445; kandice.motley@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study group assignment will be determined by the research pharmacist using a random number generator within blocks of four participants. Participant group assignment will be disclosed only at time of data analysis or in case of emergency.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind, placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 15, 2023
• Study Start: August 15, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)