[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615242":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":103,"collaborators":28,"id":105,"slug":28,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":28,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Participants with sporadic amyotrophic lateral sclerosis (sALS) will be administered INS1202, IT injection at dose level 1 on Day 1.",[13],"Genetic: INS1202",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 2 on Day 1.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 3 on Day 1.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"GENETIC","INS1202","Suspension for injection.",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Insmed Medical Information","CONTACT","1-844-446-7633","medicalinformation@insmed.com",[36,52,64,77,90],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"USA004","RECRUITING","La Jolla","California","92037","United States",{"type":44,"coordinates":45},"Point",[46,47],-117.2742,32.84727,{"lat":47,"lon":46},[50],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":51},"rprevite@health.ucsd.edu",{"facility":53,"status":38,"city":54,"state":40,"zip":55,"country":42,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"USA002","Palo Alto","94304",{"type":44,"coordinates":57},[58,59],-122.14302,37.44188,{"lat":59,"lon":58},[62],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":63},"NEUROMUSCULARRESEARCH@STANFORD.EDU",{"facility":65,"status":38,"city":66,"state":67,"zip":68,"country":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"USA001","Columbia","Missouri","65211",{"type":44,"coordinates":70},[71,72],-92.33407,38.95171,{"lat":72,"lon":71},[75],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":76},"heathermchatton@health.missouri.edu",{"facility":78,"status":38,"city":79,"state":80,"zip":81,"country":42,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"USA007","Columbus","Ohio","43221",{"type":44,"coordinates":83},[84,85],-82.99879,39.96118,{"lat":85,"lon":84},[88],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":89},"ALSResearch@osumc.edu",{"facility":91,"status":38,"city":92,"state":93,"zip":94,"country":42,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"USA006","Philadelphia","Pennsylvania","19107",{"type":44,"coordinates":96},[97,98],-75.16362,39.95238,{"lat":98,"lon":97},[101],{"name":28,"role":32,"phone":28,"phoneExt":28,"email":102},"Gemma.krautzel@jefferson.edu",{"type":104,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100615242",false,"NCT07290062","A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis","ARMOR","Key Inclusion Criteria: -\n\n* Participant with body mass index (BMI) ≥18 kilograms per square meter (kg\u002Fm\\^2).\n* Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.\n* Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.\n* SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.\n* Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.\n* Baseline ALSFRS-R ≥ 24.\n* ALS disease duration ≤ 42 months.\n\nKey Exclusion Criteria: -\n\n* Previous treatment for ALS with cellular or gene therapies.\n* Any investigational medication or treatment (for ALS or other condition).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","79 Years",{"count":116,"type":117},23,"ESTIMATED","INTERVENTIONAL",[120],"PHASE1","The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\\u003C80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.",[123],"Amyotrophic Lateral Sclerosis","2026-06-10",{"date":126,"type":127},"2026-06-12","ACTUAL",{"date":129,"type":127},"2026-01-09",{"date":131,"type":117},"2030-03-31",{"name":133,"class":6},"Insmed Gene Therapy LLC",5]