[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":65,"collaborators":68,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":32,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Montelukast Group","EXPERIMENTAL","Montelukast two capsules of 20 mg (40 mg total) taken by mouth once daily for ten weeks",[13],"Drug: Montelukast",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Microcrystalline cellulose two capsules taken by mouth once daily for ten weeks",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Montelukast","This group will receive the montelukast treatment.",[9],[27],"Singulair",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","This group will receive a placebo pill instead of montelukast",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Drew A Helmer, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Jason K Aguilar, BA","CONTACT","713-440-4633","jason.aguilar@va.gov",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Kandice Motley, BS","713-440-4445","kandice.motley@bcm.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Michael E. DeBakey VA Medical Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-95.36327,29.76328,{"lat":60,"lon":59},[63],{"name":44,"role":40,"phone":45,"phoneExt":32,"email":64},"Kandice.Motley@va.gov",{"type":36,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Drew Helmer","Professor",[69,71],{"name":49,"class":70},"FED",{"name":72,"class":6},"Texas A&M University","100515500","phase-1-clinical-evaluation-of-montelukast-in-veterans-with-gulf-war-illness-100515500",false,"NCT05992311","Clinical Evaluation of Montelukast in Veterans With Gulf War Illness","Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI)","(GWI)","Inclusion Criteria:\n\n* 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\n* 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:\n\n  1. fatigue\u002Fsleep disturbances\n  2. neurological\u002Fcognitive\u002Fmood symptoms\n  3. somatic pain\n  4. gastrointestinal problems\n  5. respiratory symptoms\n  6. skin symptoms\n* Self-reported cognitive dysfunction based on a T-score of 40 or less on the PROMIS v2.0 Cognitive Function 8a short form\n* Be able to:\n\n  * provide written consent and be able to communicate with the research team in verbal and written English\n  * attend the two in-person study encounters\n  * have reliable telephone service for the eight weekly telephone encounters\n\nExclusion Criteria:\n\n* Diagnosed by a physician with any chronic condition that may explain their profile of symptoms or prevent their ability to accurately report them including:\n\n  * chronic autoimmune conditions\n  * systemic inflammatory conditions\n  * cancer not in remission at least 5 years\n  * congestive heart failure\n  * anemia\n  * multiple sclerosis\n  * amyotrophic lateral sclerosis (ALS)\n  * poorly controlled diabetes\n  * post-chemo or radiation syndromes\n  * sickle cell anemia\n  * symptomatic Coronary Artery Disease (CAD)\n  * chronic liver disease\n  * chemical insufficiency\n  * morbid obesity (body mass index (BMI) \\>= 40)\n  * human immunodeficiency virus (HIV)\n  * alcohol\u002Fsubstance use disorder\u002Fstimulant\u002Fopioid\u002Fother depressant misuse in the past year\n  * major mental health condition (e.g., psychosis, suicidal ideations, major depressive disorder) that interferes with their ability to accurately report symptoms\n  * 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)\n  * elevated liver enzymes (2.5 times upper limit of normal) at baseline visit\n  * estimated glomerular filtration rate less than 60 ml\u002Fmin\u002F1.73 sqm at baseline visit\n  * hemoglobin less than 10 g\u002FL at baseline visit\n  * 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\n* Changes in medications for chronic conditions in the 3 months preceding enrollment (based on self-report)\n* Suicidal ideation based on their responses on the Columbia Suicide Risk Inventory\n* Prescribed or taking Montelukast in the past 6 months for any reason\n* Taking 2 or more medications with moderate interactions with Montelukast\n* Pregnancy or intention to become pregnant\n* Active homicidal ideation\n* COVID-19 illness (confirmed or suspected) without recovery to pre-COVID health status","ALL","50 Years","70 Years",{"count":85,"type":86},80,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","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.",[92],"Gulf War Syndrome",[23],"2025-08-15",{"date":96,"type":97},"2025-08-20","ACTUAL",{"date":94,"type":97},{"date":100,"type":86},"2028-08",{"name":5,"class":6},1]