[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638318":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":102,"collaborators":104,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":22,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":22,"studyType":122,"phases":123,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":62,"whyStopped":22,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Northwell Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Galantamine ER","EXPERIMENTAL","All participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups.",[13],"Drug: Galantamine Hydrobromide Extended Release",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Galantamine Hydrobromide Extended Release","Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks.",[9],[21],"Razadyne ER",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Ona Bloom, PhD","CONTACT","516-562-1309","obloom@northwell.edu",[30,61,82],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Kessler Institute for Rehabilitation","NOT_YET_RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-74.23904,40.79871,{"lat":42,"lon":41},[45,49,54,57,59],{"name":46,"role":26,"phone":47,"phoneExt":22,"email":48},"Trevor Dyson-Hudson, MD","917-838-3143","tdysonhudson@kesslerfoundation.org",{"name":50,"role":26,"phone":51,"phoneExt":52,"email":53},"Matthew Maher, MS","718-584-9000","1706","Matthew.Maher@va.gov",{"name":55,"role":56,"phone":22,"phoneExt":22,"email":22},"James Wilson, DO","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":22,"phoneExt":22,"email":22},"Chris Cirnigliaro, PhD",{"name":46,"role":60,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":36,"countryCode":37,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"RECRUITING","Manhasset","New York","11030",{"type":39,"coordinates":67},[68,69],-73.69957,40.79788,{"lat":69,"lon":68},[72,76,79,80],{"name":73,"role":26,"phone":74,"phoneExt":22,"email":75},"Welmi Pello, MPH, RN","516-562-1331","wpello@northwell.edu",{"name":77,"role":26,"phone":74,"phoneExt":22,"email":78},"Joy Cambe, MD, MPH","jcambe@northwell.edu",{"name":25,"role":60,"phone":22,"phoneExt":22,"email":22},{"name":81,"role":56,"phone":22,"phoneExt":22,"email":22},"Adam B Stein, MD",{"facility":83,"status":62,"city":84,"state":64,"zip":85,"country":36,"countryCode":37,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"James J. Peters VA Medical Center","The Bronx","10468",{"type":39,"coordinates":87},[88,89],-73.86641,40.84985,{"lat":89,"lon":88},[92,96,100],{"name":93,"role":26,"phone":51,"phoneExt":94,"email":95},"Dylan Arnero, MA","3128","Dylan.Arnero@va.gov",{"name":97,"role":26,"phone":51,"phoneExt":98,"email":99},"Genevieve Curtis","3123","Genevieve.Curtis@va.gov",{"name":101,"role":60,"phone":22,"phoneExt":22,"email":22},"Jill Wecht, EdD",{"type":103,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[105,107],{"name":106,"class":6},"Bronx Veterans Medical Research Foundation, Inc",{"name":31,"class":108},"INDUSTRY","100638318","phase-2-pilot-study-of-galantamine-to-treat-metabolic-syndrome-in-people-with-chronic-traumatic-spinal-cord-injury-sci-100638318",false,"NCT07625332","Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Inclusion Criteria:\n\n* Adults aged 21-75 years (male or female)\n* Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)\n* Wheelchair user for community mobility\n* Injury level of tetraplegia (cervical level) or paraplegia (all levels)\n* SCI-specific obesity indicated by waist circumference ≥94 cm\n* Resting heart rate \\>45 bpm based on 10 measurements over 10 minutes\n* Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG\n* Tolerable bowel routine indicated by a score of \\\u003C10 on the International SCI Bowel Function Data Set (ISCI-BDS)\n* Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg\u002FdL, (3) dyslipidemia: high triglycerides ≥150 mg\u002FdL or low HDL cholesterol \\\u003C40 mg\u002FdL for men and \\\u003C50 mg\u002FdL for women, (4) C-reactive protein (CRP) levels \\>1 mg\u002FdL\n* Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures\n* Willingness to comply with all study procedures and availability for the duration of the study\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Diagnosis of neurological injury or condition other than SCI\n* Progressive condition that would be expected to change neurological status\n* Signs and symptoms of cardiovascular disease or cardiac arrhythmias\n* Resting heart rate \\\u003C45 bpm\n* Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction\n* Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician\n* Psychopathology documented in the medical record or history that may conflict with study objectives\n* Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study\n* Active cancer or currently in treatment for cancer\n* Triglyceride levels ≥400 mg\u002FdL\n* Chronic use of medications with known or probable interactions with galantamine\n* Enrolled in another research study that is likely to interfere with conduct or results of the current study\n* Any other reason the site physician feels that participation is contraindicated","ALL","21 Years","75 Years",{"count":120,"type":121},60,"ESTIMATED","INTERVENTIONAL",[124,125],"PHASE2","PHASE3","The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.",[128,129,130,131],"Spinal Cord Injury","Traumatic Spinal Cord Injury","Paraplegia and Tetraplegia","Metabolic Syndrome",[133,134,135,136],"spinal cord injury","tetraplegia","paraplegia","metabolic syndrome","2026-05-28",{"date":139,"type":140},"2026-06-04","ACTUAL",{"date":142,"type":121},"2026-06-15",{"date":144,"type":121},"2027-12",{"name":5,"class":6},3]