[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648332":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Lexeo Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LX2006","EXPERIMENTAL","Cohort 1: Participants ≥16 years of age with FA-CM Cohort 2: Participants ≥6 to \\\u003C16 years of age with FA-CM. As Cohort 2 will not be randomized, all participants will receive LX2006 upon enrollment. Participants in Cohort 2 will be enrolled after safety is assessed in a group of participants in Cohort 1.",[13],"Genetic: LX2006",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","OTHER","Cohort 1: Participants ≥16 years of age with FA-CM Participants will receive usual care for 26 weeks before receiving treatment with LX2006 (single crossover).",[19],"Other: Usual Care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"GENETIC","Adeno-associated viral vector encoding the FXN gene (AAVrh.10hFXN)",[9],null,{"type":16,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Lexeo Clinical Trials","Lexeo Therapeutics, Inc.","STUDY_DIRECTOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","212-547-9879","clinicaltrials@lexeotx.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of South Florida","RECRUITING","Tampa","Florida","33612","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-82.45843,27.94752,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":25,"email":57},"Lucretia Campbell","813-974-5633","lcampbel@usf.edu",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648332","phase-2-study-of-lx2006-gene-therapy-in-friedreich-ataxia-cardiomyopathy-100648332",false,"NCT07721025","Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy","A Phase 2, Multicenter, Open-label, Randomized, Controlled Study of LX2006 Gene Therapy in Participants With Friedreich Ataxia Cardiomyopathy (SUNRISE-FA 2)","SUNRISE-FA 2","Inclusion Criteria:\n\n* Male or female, age at least 6 years at the time of signing the informed consent (and assent, if applicable).\n* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on the frataxin gene)\n* Onset of FA on or before 25 years of age\n* Confirmed left ventricular hypertrophy and abnormal left ventricular mass index\n* Left ventricular ejection fraction at least 30%\n* Anti-AAVrh.10 total antibody titer less than the protocol-specified maximum level\n\nExclusion Criteria:\n\n* Presence of other forms of cardiomyopathy that contribute to heart failure\n* Current use of inotrope infusion or presence of a ventricular assist device\n* Contraindication to cardiac MRI\n* Prior organ transplant\n* Previous gene transfer or cell therapy\n* Poorly controlled diabetes (hemoglobin A1c ≥8%)\n* Active hematologic or solid organ cancer\n\nOther inclusion\u002Fexclusion criteria to be applied as per protocol.","ALL","6 Years",{"count":71,"type":72},26,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).",[78,79],"Friedreich Ataxia","Cardiomyopathy, Secondary",[81,82,78,83,84,85,86,87,88,89,90,91,92,93,94,95,96,9,66,97,98],"Friedreich Ataxia Cardiomyopathy","FA-CM","Friedreich's Ataxia","FA","FRDA","Cardiomyopathy","Genetic Cardiomyopathy","Mitochondrial Cardiomyopathy","Cardiac Disease","Left Ventricular Hypertrophy","Hypertrophic Cardiomyopathy (Non-Obstructive)","HCM","Gene Therapy","FXN Gene","FXN","Frataxin Gene","SUNRISE-FA","CLARITY","2026-07-20",{"date":101,"type":102},"2026-07-22","ACTUAL",{"date":104,"type":102},"2026-06-25",{"date":106,"type":72},"2032-06",{"name":5,"class":6},1]