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New treatment option for Gulf War Syndrome
Official title Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
ClinicalTrials.gov ID: NCT05992311
What this study is testing
What is Montelukast?
Montelukast is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gulf war syndrome.
Also referred to as Singulair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- 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...
- fatigue/sleep disturbances
- neurological/cognitive/mood symptoms
- somatic pain
You likely can't join if
- Diagnosed by a physician with any chronic condition that may explain their profile of symptoms or prevent their ability to accurately report them...
- chronic autoimmune conditions
- systemic inflammatory conditions
- cancer not in remission at least 5 years
- congestive heart failure
- anemia
See the full eligibility 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...
- fatigue/sleep disturbances
- neurological/cognitive/mood symptoms
- somatic pain
- gastrointestinal problems
- respiratory symptoms
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.