Montelukast for Gulf War Syndrome ((GWI) Trial)

Palo Alto (17 mi)

Overseen byDrew A Helmer, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for U.S. Gulf War veterans who served between August 2, 1990, and December 31, 1991, and are experiencing symptoms like somatic pain, fatigue or sleep issues, respiratory or skin conditions, cognitive dysfunction with a specific test score threshold, mood disturbances or gastrointestinal problems. Participants must be able to communicate in English and attend two in-person study visits.

Inclusion Criteria

I can attend the two required in-person study visits.

Treatment Details

The trial is testing Montelukast (MLK), an FDA-approved asthma drug that may improve brain function by reducing inflammation. It's being compared to a placebo to see if it can help with cognitive and mood issues in veterans with Gulf War Illness.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Montelukast GroupExperimental Treatment1 Intervention

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

Group II: Placebo GroupPlacebo Group1 Intervention

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

Montelukast is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Singulair for: