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NCT05992311 · ClinicalTrials.gov registry record · Phase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
A Phase 1 study of Gulf War Syndrome, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05992311: Recruiting Phase 1 study of Gulf War Syndrome, sponsored by Baylor College of Medicine.
NCT05992311 is a Phase 1 study of Gulf War Syndrome that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 80 participants, below the 125-participant average among 8 other Gulf War Syndrome trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05992311, a Phase 1 study of Gulf War Syndrome, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Concentrations in the brain-derived extracellular vesicles collected from the circulating peripheral blood.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Montelukast
Study Locations (1)
Texas
- Michael E. DeBakey VA Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
What NCT05992311 shows while recruiting
NCT05992311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 125-participant average among 8 other Gulf War Syndrome trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Gulf War Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05992311 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05992311 about?
NCT05992311 is a clinical study titled "Clinical Evaluation of Montelukast in Veterans With Gulf War Illness". 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 m...
What is the current status of trial NCT05992311?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-08-15. Estimated completion is 2028-08.
What conditions does trial NCT05992311 study?
This clinical trial studies the following conditions: Gulf War Syndrome.
What interventions are being tested in trial NCT05992311?
The interventions under investigation include: Placebo (OTHER), Montelukast (DRUG).
Who is sponsoring clinical trial NCT05992311?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05992311 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gulf War Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05992311's enrollment target sits among peer trials
80 7th of 8 higher than 2 of 8 other Gulf War Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gulf War Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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