[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06420297":3,"trial-entities:NCT06420297":306,"trial-summary:NCT06420297":309},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":65,"locations":68,"central_contacts":302,"overall_officials":303,"references":304,"see_also_links":305},"NCT06420297","ACP-101-303","OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome","A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome","ENROLLING_BY_INVITATION","2029-06","2025-12","2025-12-03","2024-03-11","ACADIA Pharmaceuticals Inc.","INDUSTRY",true,"To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS","This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.",[19],"Hyperphagia in Prader-Willi Syndrome",[21,22,23],"Opel-label extension","safety","tolerability","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},160,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Carbetocin","Carbetocin nasal spray 3.2 mg three times daily (TID)",[37],"Drug: Carbetocin",[39],"ACP-101",[41],{"measure":42,"description":43,"timeFrame":44},"Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions","Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group.","Baseline to 36 months",[],"ALL","5 Years","30 Years",false,{"inclusion":51,"exclusion":56,"raw_text":64},[52,53,54,55],"Has completed the Week12\u002FEOT visit of the antecedent, Study ACP-101-302","Met all entry criteria for the antecedent study","May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.","Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.",[57,58,59,60,61,62,63],"History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.","Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder","History of suicide attempt or inpatient psychiatric hospitalization","Has a clinically significant abnormality in vital signs at Baseline","Has an average QTcF interval of \\>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)","Has developed a clinically significant ECG finding during the antecedent study","Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study","Inclusion Criteria:\n\n* Has completed the Week12\u002FEOT visit of the antecedent, Study ACP-101-302\n* Met all entry criteria for the antecedent study\n* May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.\n* Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.\n\nExclusion Criteria:\n\n* History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.\n* Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder\n* History of suicide attempt or inpatient psychiatric hospitalization\n* Has a clinically significant abnormality in vital signs at Baseline\n* Has an average QTcF interval of \\>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)\n* Has developed a clinically significant ECG finding during the antecedent study\n* Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study\n\nAdditional inclusion\u002Fexclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.",[66,67],"CHILD","ADULT",[69,78,86,94,101,108,116,124,132,140,148,155,163,171,179,187,195,202,210,218,227,235,244,252,259,267,274,281,288,295],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Children's of Alabama","Birmingham","Alabama","35233","United States",{"lat":76,"lon":77},33.52066,-86.80249,{"facility":79,"city":80,"state":81,"zip":82,"country":74,"geoPoint":83},"Phoenix Children's Hospital","Phoenix","Arizona","85006",{"lat":84,"lon":85},33.44838,-112.07404,{"facility":87,"city":88,"state":89,"zip":90,"country":74,"geoPoint":91},"University of California Irvine","Orange","California","92697",{"lat":92,"lon":93},33.78779,-117.85311,{"facility":95,"city":96,"state":89,"zip":97,"country":74,"geoPoint":98},"Stanford University School of Medicine","Palo Alto","94304",{"lat":99,"lon":100},37.44188,-122.14302,{"facility":102,"city":103,"state":89,"zip":104,"country":74,"geoPoint":105},"Rady Children's Hospital San Diego","San Diego","92123",{"lat":106,"lon":107},32.71571,-117.16472,{"facility":109,"city":110,"state":111,"zip":112,"country":74,"geoPoint":113},"Children's Hospital Colorado","Aurora","Colorado","80045",{"lat":114,"lon":115},39.72943,-104.83192,{"facility":117,"city":118,"state":119,"zip":120,"country":74,"geoPoint":121},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"lat":122,"lon":123},41.85003,-87.65005,{"facility":125,"city":126,"state":127,"zip":128,"country":74,"geoPoint":129},"University of Iowa","Iowa City","Iowa","52242",{"lat":130,"lon":131},41.66113,-91.53017,{"facility":133,"city":134,"state":135,"zip":136,"country":74,"geoPoint":137},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":138,"lon":139},42.35843,-71.05977,{"facility":141,"city":142,"state":143,"zip":144,"country":74,"geoPoint":145},"Children's Mercy Kansas City","Kansas City","Missouri","64108",{"lat":146,"lon":147},39.09973,-94.57857,{"facility":149,"city":150,"state":143,"zip":151,"country":74,"geoPoint":152},"SSM Health\u002FSaint Louis University","St Louis","63104",{"lat":153,"lon":154},38.62727,-90.19789,{"facility":156,"city":157,"state":158,"zip":159,"country":74,"geoPoint":160},"Maimonides Medical Center","Brooklyn","New York","11219",{"lat":161,"lon":162},40.6501,-73.94958,{"facility":164,"city":165,"state":166,"zip":167,"country":74,"geoPoint":168},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"lat":169,"lon":170},39.96118,-82.99879,{"facility":172,"city":173,"state":174,"zip":175,"country":74,"geoPoint":176},"UPMC-Children's Hospital Pittsburgh","Pittsburgh","Pennsylvania","15224",{"lat":177,"lon":178},40.44062,-79.99589,{"facility":180,"city":181,"state":182,"zip":183,"country":74,"geoPoint":184},"Vanderbilt Clinical Research Center","Nashville","Tennessee","37232",{"lat":185,"lon":186},36.16589,-86.78444,{"facility":188,"city":189,"state":190,"zip":191,"country":74,"geoPoint":192},"Cook Children's Health Care System","Fort Worth","Texas","79104",{"lat":193,"lon":194},32.72541,-97.32085,{"facility":196,"city":197,"state":190,"zip":198,"country":74,"geoPoint":199},"Christus Children's","San Antonio","78207",{"lat":200,"lon":201},29.42412,-98.49363,{"facility":203,"city":204,"state":205,"zip":206,"country":74,"geoPoint":207},"University of Utah","Salt Lake City","Utah","84108",{"lat":208,"lon":209},40.76078,-111.89105,{"facility":211,"city":212,"state":213,"zip":214,"country":74,"geoPoint":215},"Seattle Children's Hospital","Seattle","Washington","98105",{"lat":216,"lon":217},47.60621,-122.33207,{"facility":219,"city":220,"state":221,"zip":222,"country":223,"geoPoint":224},"Alberta Diabetes Institute","Edmonton","Alberta","T6G 2E1","Canada",{"lat":225,"lon":226},53.55014,-113.46871,{"facility":228,"city":229,"state":230,"zip":231,"country":223,"geoPoint":232},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5",{"lat":233,"lon":234},45.50884,-73.58781,{"facility":236,"city":237,"state":238,"zip":239,"country":240,"geoPoint":241},"Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital des Enfants","Toulouse","Cedex 9 Occitanie","31059","France",{"lat":242,"lon":243},43.60426,1.44367,{"facility":245,"city":246,"zip":247,"country":248,"geoPoint":249},"KJF Klinik Josefinum gGmbH","Augsburg","86154","Germany",{"lat":250,"lon":251},48.37154,10.89851,{"facility":253,"city":254,"zip":255,"country":248,"geoPoint":256},"Universitätsklinikum Essen","Essen","45147",{"lat":257,"lon":258},51.45657,7.01228,{"facility":260,"city":261,"zip":262,"country":263,"geoPoint":264},"Parc Taulí Hospital Universitari","Barcelona","08208","Spain",{"lat":265,"lon":266},41.38879,2.15899,{"facility":268,"city":269,"zip":270,"country":263,"geoPoint":271},"Hospital General Universitario Gregorio Marañón","Madrid","28007",{"lat":272,"lon":273},40.4165,-3.70256,{"facility":275,"city":276,"zip":277,"country":263,"geoPoint":278},"Hospital Regional Universitario de Málaga","Málaga","29009",{"lat":279,"lon":280},36.72016,-4.42034,{"facility":282,"city":71,"zip":283,"country":284,"geoPoint":285},"University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital","B9 5SS","United Kingdom",{"lat":286,"lon":287},52.48142,-1.89983,{"facility":289,"city":290,"zip":291,"country":284,"geoPoint":292},"Royal Hospital for Children Glasgow Clinical","Glasgow","G51 4TF",{"lat":293,"lon":294},55.86515,-4.25763,{"facility":296,"city":297,"zip":298,"country":284,"geoPoint":299},"Barts Health NHS Trust - The Royal London Hospital","London","E1 1B6",{"lat":300,"lon":301},51.50853,-0.12574,[],[],[],[],{"nct_id":4,"conditions":307,"biomarkers":308},[19],[],{"nct_id":4,"found":49,"summary":310,"prompt_version":310},null]