Asthma drug may ease brain fog in gulf war illness

NCT ID NCT05992311

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether montelukast, an asthma drug, can improve cognitive and mood problems in veterans with Gulf War Illness. The drug may reduce brain inflammation, which is thought to contribute to symptoms. Researchers will give montelukast or a placebo to 80 veterans and measure changes in brain-related markers and thinking tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
montelukast (Singulair), an FDA-approved asthma drug
What this could lead to
If it works, montelukast could become a treatment for cognitive and mood problems in Gulf War veterans, potentially improving daily function.
What could go wrong
This is an early-phase trial with 80 participants, so results may not hold up in larger studies. Montelukast can cause side effects like headache or stomach upset, and it may not reduce brain inflammation as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. fatigue/sleep disturbances 2. neurological/cognitive/mood symptoms 3. somatic pain 4. gastrointestinal problems 5. respiratory symptoms 6. 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 Exclusion Criteria: * 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) * human immunodeficiency virus (HIV) * alcohol/substance use disorder/stimulant/opioid/other depressant misuse in the past year * major mental health condition (e.g., psychosis, suicidal ideations, major depressive disorder) that interferes with their ability to accurately report symptoms * hospitalized or undergoing invasive procedures in the past 12 months due to exacerbations of any chronic conditions (such as diabetes, coronary artery disease, hypertension, or emphysema) * elevated liver enzymes (2.5 times upper limit of normal) at baseline visit * estimated glomerular filtration rate less than 60 ml/min/1.73 sqm at baseline visit * hemoglobin less than 10 g/L at baseline visit * evidence of poorly controlled chronic conditions listed above, or others that may mimic GWI as per the PI, either by self-report, Veterans Health Administration (VHA) electronic health record information review, laboratory testing or physical examination * Changes in medications for chronic conditions in the 3 months preceding enrollment (based on self-report) * Suicidal ideation based on their responses on the Columbia Suicide Risk Inventory * Prescribed or taking Montelukast in the past 6 months for any reason * Taking 2 or more medications with moderate interactions with Montelukast * Pregnancy or intention to become pregnant * Active homicidal ideation * COVID-19 illness (confirmed or suspected) without recovery to pre-COVID health status

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Michael E. DeBakey VA Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

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