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Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

NCT05992311 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

DRUG

Montelukast

This group will receive the montelukast treatment.

OTHER

Placebo

This group will receive a placebo pill instead of montelukast

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Texas A&M University

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Drew A Helmer, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2028-04-30
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05992311 on ClinicalTrials.gov