Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05992311
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gulf War Syndrome

Eligibility Criteria

Sex
ALL
Age
50 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Montelukast — DRUG
    This group will receive the montelukast treatment.
  • Placebo — OTHER
    This group will receive a placebo pill instead of montelukast

Study Details

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.

Key Dates

Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical CenterHoustonTexas77030
Kandice Motley, BS
[email protected]
713-440-4445

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Michael E. DeBakey VA Medical Center· Houston, TX

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