[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05967351":3,"trial-entities:NCT05967351":383,"trial-summary:NCT05967351":386},{"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":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":49,"sex":69,"minimum_age":17,"maximum_age":17,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":78,"locations":82,"central_contacts":379,"overall_officials":380,"references":381,"see_also_links":382},"NCT05967351","SRP-9001-305","A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study","A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study","ENROLLING_BY_INVITATION","2033-10-31","2026-02","2026-02-06","2023-09-27","Sarepta Therapeutics, Inc.","INDUSTRY",true,"The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study.",null,[19],"Duchenne Muscular Dystrophy",[19,21,22,23,24,25,26],"DMD","Pediatric","Long-term","Follow-up","Safety","Efficacy","INTERVENTIONAL","OTHER",[30],"PHASE3",{"count":32,"type":33},400,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"GENETIC","delandistrogene moxeparvovec","No study drug will be administered as part of this study. Eligible participants who received treatment with delandistrogene moxeparvovec during a previous clinical study will be included.",[40],"Delandistrogene Moxeparvovec",[42,43,44],"SRP-9001","delandistrogene moxeparvovec-rokl","ELEVIDYS",[46],{"measure":47,"timeFrame":48},"Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)","Up to 10 years",[50,53,55,57,59,61,63,65,67],{"measure":51,"timeFrame":52},"Change in the North Star Ambulatory Assessment (NSAA) Total Score From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation","Baseline, up to 10 years",{"measure":54,"timeFrame":52},"Change in Time to Rise From Floor From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":56,"timeFrame":52},"Change in the Time of 10-meter Walk\u002FRun (10MWR) From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":58,"timeFrame":52},"Change in Performance of Upper Limb (PUL) (Version 2.0) Total Scores From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":60,"timeFrame":52},"Change in PUL (Version 2.0) Domain Specific Scores From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":62,"timeFrame":52},"Change in Forced Vital Capacity Percent (FVC%) Predicted From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":64,"timeFrame":52},"Change in Peak Expiratory Flow Percent (PEF%) Predicted From Pre-infusion Baseline to the End of the Study Participation of Delandistrogene Moxeparvovec",{"measure":66,"timeFrame":52},"Change in Cardiac Magnetic Resonance Imaging (MRI) Findings From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation",{"measure":68,"timeFrame":52},"Change in Musculoskeletal MRI Findings From Pre-infusion Baseline of Delandistrogene Moxeparvovec to the End of the Study Participation","MALE",false,{"inclusion":72,"exclusion":75,"raw_text":77},[73,74],"Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.","Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.",[76],"Not applicable","Inclusion Criteria:\n\n* Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.\n* Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.\n\nExclusion Criteria:\n\n* Not applicable",[79,80,81],"CHILD","ADULT","OLDER_ADULT",[83,92,100,107,114,121,129,137,145,153,161,169,177,184,191,199,207,215,223,231,239,247,255,264,273,279,287,294,301,310,318,324,333,340,348,355,364,372],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Arkansas Children's Hospital","Little Rock","Arkansas","72202","United States",{"lat":90,"lon":91},34.74648,-92.28959,{"facility":93,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"UCLA Medical Center","Los Angeles","California","90095",{"lat":98,"lon":99},34.05223,-118.24368,{"facility":101,"city":102,"state":95,"zip":103,"country":88,"geoPoint":104},"Lucile Packard Children's Hospital Stanford (LPCH)","Palo Alto","94304",{"lat":105,"lon":106},37.44188,-122.14302,{"facility":108,"city":109,"state":95,"zip":110,"country":88,"geoPoint":111},"University of California, Davis","Sacramento","95817",{"lat":112,"lon":113},38.58157,-121.4944,{"facility":115,"city":116,"state":95,"zip":117,"country":88,"geoPoint":118},"Rady Children's Hospital","San Diego","92123",{"lat":119,"lon":120},32.71571,-117.16472,{"facility":122,"city":123,"state":124,"zip":125,"country":88,"geoPoint":126},"Children's Hospital of Colorado","Aurora","Colorado","80045-7106",{"lat":127,"lon":128},39.72943,-104.83192,{"facility":130,"city":131,"state":132,"zip":133,"country":88,"geoPoint":134},"University of Florida Clinical Research Center","Gainesville","Florida","32610",{"lat":135,"lon":136},29.65163,-82.32483,{"facility":138,"city":139,"state":140,"zip":141,"country":88,"geoPoint":142},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"lat":143,"lon":144},41.85003,-87.65005,{"facility":146,"city":147,"state":148,"zip":149,"country":88,"geoPoint":150},"University of Iowa ICTS Clinical Research Unit","Iowa City","Iowa","52242",{"lat":151,"lon":152},41.66113,-91.53017,{"facility":154,"city":155,"state":156,"zip":157,"country":88,"geoPoint":158},"The Johns Hopkins Hospital, Rubenstein Child Health Bldg","Baltimore","Maryland","21287",{"lat":159,"lon":160},39.29038,-76.61219,{"facility":162,"city":163,"state":164,"zip":165,"country":88,"geoPoint":166},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":167,"lon":168},42.35843,-71.05977,{"facility":170,"city":171,"state":172,"zip":173,"country":88,"geoPoint":174},"Washington University School of Medicine","St Louis","Missouri","63110",{"lat":175,"lon":176},38.62727,-90.19789,{"facility":178,"city":179,"state":179,"zip":180,"country":88,"geoPoint":181},"Columbia University Pediatric Neuromuscular Center","New York","10032",{"lat":182,"lon":183},40.71427,-74.00597,{"facility":185,"city":186,"state":179,"zip":187,"country":88,"geoPoint":188},"University of Rochester Medical Center","Rochester","14642",{"lat":189,"lon":190},43.15478,-77.61556,{"facility":192,"city":193,"state":194,"zip":195,"country":88,"geoPoint":196},"Lenox Baker Children's Hospital (Duke University)","Durham","North Carolina","27705",{"lat":197,"lon":198},35.99403,-78.89862,{"facility":200,"city":201,"state":202,"zip":203,"country":88,"geoPoint":204},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"lat":205,"lon":206},39.96118,-82.99879,{"facility":208,"city":209,"state":210,"zip":211,"country":88,"geoPoint":212},"Oregon Health and Science University","Portland","Oregon","97239",{"lat":213,"lon":214},45.52345,-122.67621,{"facility":216,"city":217,"state":218,"zip":219,"country":88,"geoPoint":220},"Chiildren's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"lat":221,"lon":222},39.95238,-75.16362,{"facility":224,"city":225,"state":226,"zip":227,"country":88,"geoPoint":228},"Children's Health Specialty Center","Dallas","Texas","75207",{"lat":229,"lon":230},32.78306,-96.80667,{"facility":232,"city":233,"state":234,"zip":235,"country":88,"geoPoint":236},"University of Utah Health","Salt Lake City","Utah","84132",{"lat":237,"lon":238},40.76078,-111.89105,{"facility":240,"city":241,"state":242,"zip":243,"country":88,"geoPoint":244},"Children's Hospital of The King's Daughters","Norfolk","Virginia","23510",{"lat":245,"lon":246},36.84681,-76.28522,{"facility":248,"city":249,"state":250,"zip":251,"country":88,"geoPoint":252},"Children's Hospital Wisconsin","Milwaukee","Wisconsin","53226",{"lat":253,"lon":254},43.0389,-87.90647,{"facility":256,"city":257,"state":258,"zip":259,"country":260,"geoPoint":261},"Universitair Ziekenhuis Gent, Neuromuscular Reference Centre (NMRC)","Ghent","East Flanders","9000","Belgium",{"lat":262,"lon":263},51.05,3.71667,{"facility":265,"city":266,"state":267,"zip":268,"country":269,"geoPoint":270},"Universitätsklinikum Essen - Klinik für Kinderheilkunde I","Essen","North Rhine-Westphalia","45147","Germany",{"lat":271,"lon":272},51.45657,7.01228,{"facility":274,"city":275,"country":275,"geoPoint":276},"Hong Kong Children's Hospital","Hong Kong",{"lat":277,"lon":278},22.27832,114.17469,{"facility":280,"city":281,"zip":282,"country":283,"geoPoint":284},"UOC Neurologia Pediatrica e Malattie Muscolari, Istituto G. Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico","Genova","16147","Italy",{"lat":285,"lon":286},45.21604,11.87211,{"facility":288,"city":289,"zip":290,"country":283,"geoPoint":291},"UOC Neurologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122",{"lat":292,"lon":293},42.78235,12.59836,{"facility":295,"city":296,"zip":297,"country":283,"geoPoint":298},"UOC Neuropsichiatria Infantile, Area Salute del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattoclica del Sacro Cuore","Roma","00168",{"lat":299,"lon":300},44.99364,11.10642,{"facility":302,"city":303,"state":304,"zip":305,"country":306,"geoPoint":307},"Kobe University Hospital","Kobe","Hyōgo","650-0017","Japan",{"lat":308,"lon":309},34.6913,135.183,{"facility":311,"city":312,"state":313,"zip":314,"country":306,"geoPoint":315},"National Center of Neurology and Psychiatry","Kodaira","Tokyo","187-8551",{"lat":316,"lon":317},35.72603,139.48508,{"facility":319,"city":313,"zip":320,"country":306,"geoPoint":321},"Tokyo Women's Medical University Hospital","1628666",{"lat":322,"lon":323},35.6895,139.69171,{"facility":325,"city":326,"state":327,"zip":328,"country":329,"geoPoint":330},"Hospital Sant Joan de Deu","Esplugues de Llobregat","Barcelona","08950","Spain",{"lat":331,"lon":332},41.37732,2.08809,{"facility":334,"city":335,"zip":336,"country":329,"geoPoint":337},"Hospital Universitario y Politecnico La fe. Neurology Department","Valencia","46026",{"lat":338,"lon":339},39.47391,-0.37966,{"facility":341,"city":342,"zip":343,"country":344,"geoPoint":345},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807","Taiwan",{"lat":346,"lon":347},22.61626,120.31333,{"facility":349,"city":350,"zip":351,"country":344,"geoPoint":352},"National Taiwan University Hospital","Taipei","100225",{"lat":353,"lon":354},25.05306,121.52639,{"facility":356,"city":357,"state":358,"zip":359,"country":360,"geoPoint":361},"Great Ormond Street Hospital For Children NHS Foundation Trust","London","Greater London","WC1N 1EJ","United Kingdom",{"lat":362,"lon":363},51.50853,-0.12574,{"facility":365,"city":366,"state":367,"zip":368,"country":360,"geoPoint":369},"Oxford University Hospitals NHS Foundation Trust","Oxford","Oxfordshire","OX3 9DU",{"lat":370,"lon":371},51.75222,-1.25596,{"facility":373,"city":374,"zip":375,"country":360,"geoPoint":376},"Institute of Translational and Clinical Research","Newcastle upon Tyne","NE1 3BZ",{"lat":377,"lon":378},54.97328,-1.61396,[],[],[],[],{"nct_id":4,"conditions":384,"biomarkers":385},[19],[],{"nct_id":4,"found":70,"summary":17,"prompt_version":17}]