[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651924":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":22,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":10,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":10,"enrollmentInfo":33,"targetDuration":10,"studyType":36,"phases":10,"briefSummary":37,"conditions":38,"keywords":40,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":10},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Onasemnogene Abeparvovec Intrathecal Group",null,"SMA patients treated with onasemnogene abeparvovec intrathecal injection in Japan.",[13],{"name":14,"affiliation":14,"role":15},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":14,"role":18,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651924","a-study-of-the-safety-and-effectiveness-of-onasemnogene-abeparvovec-zolgensma-intrathecal-injection-in-spinal-muscular-atrophy-patients-100651924",false,"NCT07767890","A Study of the Safety and Effectiveness of Onasemnogene Abeparvovec (Zolgensma) Intrathecal Injection in Spinal Muscular Atrophy Patients","Specified Use-Results Survey of Zolgensma Intrathecal Injection (Spinal Muscular Atrophy)","Inclusion criteria:\n\n• All patients treated with onasemnogene abeparvovec.\n\nExclusion criteria:\n\n• Patients who have received onasemnogene abeparvovec for unapproved indications under the Clinical Trials Act or GCP (eg, investigator-initiated clinical trial).","ALL","2 Years",{"count":34,"type":35},80,"ESTIMATED","OBSERVATIONAL","This study aims to assess the safety and effectiveness of onasemnogene abeparvovec intrathecal injection in spinal muscular atrophy (SMA) patients in clinical practice in Japan.\n\nThis is a non-interventional study and does not impose a therapy protocol, diagnostic\u002Ftherapeutic procedure, or a visit schedule. Patients will be treated according to the Japan package insert. Data will be collected using a case registration form (CRF) completed by the investigator at each study site.",[39],"Spinal Muscular Atrophy",[41],"Onasemnogene Abeparvovec","NOT_YET_RECRUITING","2026-08-11",{"date":45,"type":46},"2026-08-17","ACTUAL",{"date":48,"type":35},"2026-10-30",{"date":50,"type":35},"2031-03-31",{"name":14,"class":6}]