[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651293":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":110,"whyStopped":31,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Guanfacine","EXPERIMENTAL","Participants receive oral guanfacine during one 4-week treatment period, with dose escalation permitted according to protocol if clinically indicated.",[13,14,15],"Drug: Guanfacine (GFC)","Drug: Cromolyn Sodium","Drug: Placebo",{"label":17,"type":10,"description":18,"interventionNames":19},"Cromolyn Sodium","Participants receive oral cromolyn sodium during one 4-week treatment period, with protocol-defined dose escalation if needed.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR","Participants receive matched placebo during one 4-week treatment period to maintain blinding.",[13,14,15],[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Guanfacine (GFC)","Participants receive oral guanfacine for 4 weeks while continuing standardized non-pharmacologic management of POTS. Guanfacine is initiated at 1 mg once daily and may be increased to 2 mg once daily at Week 3 if adequate clinical improvement has not been achieved and the medication is well tolerated. Participants complete symptom assessments and safety evaluations throughout the treatment period.",[17,9,21],null,{"type":27,"name":17,"description":33,"armGroupLabels":34,"otherNames":31},"Participants receive oral cromolyn sodium for 4 weeks while continuing standardized non-pharmacologic management of POTS. Treatment begins at 200 mg twice daily (400 mg\u002Fday) and may be increased to 400 mg twice daily (800 mg\u002Fday). For participants who tolerate treatment but have an inadequate response, the dose may be further increased to 1,600 mg\u002Fday according to the protocol. Symptom assessments and safety evaluations are performed throughout the treatment period.",[17,9,21],{"type":27,"name":21,"description":36,"armGroupLabels":37,"otherNames":31},"Participants receive matched placebo for 4 weeks while continuing standardized non-pharmacologic management of POTS. Placebo products are matched to the active study medications, including identical dose-escalation procedures, to maintain blinding. Participants complete the same symptom assessments and safety evaluations as during the active treatment periods.",[17,9,21],[39],{"name":40,"affiliation":5,"role":41},"Malcolm Brock, MD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Kristen Rodgers, BS","CONTACT","410-955-9047","kpelosk1@jhmi.edu",[49],{"facility":50,"status":31,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Johns Hopkins Hospital","Baltimore","Maryland","21287","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-76.61219,39.29038,{"lat":60,"lon":59},[63],{"name":40,"role":41,"phone":31,"phoneExt":31,"email":31},{"type":65,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[67],{"name":68,"class":6},"Dysautonomia International","100651293","early-phase-1-guanfacine-and-cromolyn-sodium-for-pots-the-dbpots-trial-100651293",false,"NCT07757555","Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial","Efficacy and Mechanisms of Guanfacine and Cromolyn Sodium in Adults With Postural Orthostatic Tachycardia Syndrome (POTS): A Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial. Acronym is DBPOTS (Double Blind POTS)","DBPOTS","Inclusion Criteria:\n\n* Documented diagnosis of POTS per current consensus guidelines:\n* a heart rate increase of ≥30 bpm within the first 10 minutes of standing or tilt-table testing, without orthostatic hypotension (systolic BP drop ≥20 mmHg)\n* Frequent symptoms of orthostatic intolerance (e.g., dizziness, palpitations, GI complaints) persisting ≥3 months\n* Symptom onset within 3 months of a recognized POTS trigger (e.g., infection, vaccination, injury, surgery, pregnancy, or puberty)\n* Symptomatic response to mediator-targeting medications (e.g., antihistamines, mast cell stabilizers) - also eligible\n* Presence of flushing, pruritis, urticaria, or angioedema - also eligible\n* Alternative diagnoses must be excluded via prior clinical workup and laboratory assessment\n\nExclusion Criteria:\n\n* Alternative medical causes for symptoms, including:\n* Anemia,\n* Active infection,\n* Dehydration,\n* Hyperthyroidism,\n* Pheochromocytoma,\n* Adrenal insufficiency,\n* Paraneoplastic conditions\n* Active neurologic disease (including stroke and epilepsy)\n* Prolonged immobilization\n* Current use of medications that cannot be safely discontinued during study enrollment (safety-based exclusion)\n* Pregnancy or breastfeeding","ALL","18 Years","100 Years",{"count":81,"type":82},25,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","The goal of this clinical trial is to learn whether guanfacine or cromolyn sodium can improve symptoms and physical functioning in adults with Postural Orthostatic Tachycardia Syndrome (POTS). Both medications are FDA-approved for other conditions but are investigational for the treatment of POTS.\n\nThe main questions this study aims to answer are:\n\nDoes treatment with guanfacine or cromolyn sodium improve physical functioning in adults with POTS compared with placebo? Does treatment with guanfacine or cromolyn sodium improve fatigue, cognitive function (\"brain fog\"), gastrointestinal symptoms, and overall symptom burden in adults with POTS?\n\nResearchers will compare guanfacine, cromolyn sodium, and placebo to determine whether either active treatment provides greater improvement in symptoms and physical functioning than placebo.\n\nParticipants will:\n\nBe randomly assigned to receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study.\n\nContinue standard non-drug POTS management, including recommendations for fluid and salt intake, exercise, compression garments, and other lifestyle measures.\n\nComplete questionnaires that measure physical function, fatigue, cognitive symptoms, gastrointestinal symptoms, and overall health throughout the study.\n\nAttend scheduled study visits for safety monitoring and assessment of study outcomes.\n\nProvide blood, urine, and sputum samples so researchers can evaluate biomarkers related to POTS and better understand how these treatments may work.",[88,89,90,91],"Postural Orthostatic Tachycardia Syndrome (POTS)","Dysautonomia","Orthostatic Intolerance","Autonomic Nervous System Diseases",[88,89,90,93,94,95,9,17,96,97,98,99,100,101,102,103,104,105,106,107,108,109],"Autonomic Nervous System Disorders","Hyperadrenergic POTS","Adult POTS","Re-purposed FDA-approved drugs","Sympatholytic therapy","Placebo-Controlled","Phase II Exploratory Trial","Comparative Effectiveness","Autonomic Dysfunction","Voltage-Gated Sodium Channels","SCN9A","SCN10A","NaV Channels","Ion Channelopathy","Cognitive Dysfunction","Brain Fog","Fatigue","NOT_YET_RECRUITING","2026-08-10",{"date":113,"type":114},"2026-08-12","ACTUAL",{"date":116,"type":82},"2026-08-15",{"date":118,"type":82},"2028-02-02",{"name":5,"class":6},1]