[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ITF Therapeutics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100602781","a-study-evaluating-the-real-world-experience-of-givinostat-in-patients-with-duchenne-muscular-dystrophy-100602781",false,"NCT07127978","A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy","A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy","PROVIDUS","Inclusion Criteria:\n\n* Patients of any gender at least 6 years of age, diagnosed with DMD (according to genetic test) and have received a prescription for oral givinostat in accordance with the USPI.\n* Patient has provided informed consent (and assent when applicable) for participation in the study.\n* Patient's index date (first date of givinostat treatment) is no more than 6 months prior to signing of informed consent.\n* Patient has the required data available (DMD diagnosis, givinostat administration \\[dose and schedule\\], laboratory results \\[hematology and triglycerides\\]) for addressing the study objectives for the period between index date and study entry (for patients enrolled after the index date).\n\nExclusion Criteria:\n\n* Patient previously received givinostat (commercial or investigational product) and permanently discontinued treatment or patient started commercial givinostat for \\> 6 months before signing of informed consent.","ALL","6 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years of follow-up.",[25],"Duchene Muscular Dystrophy",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"DMD","DUVYZAT","U.S study","duchenne muscular dystrophy","givinostat","non-interventional study","pediatric neuromuscular disease","rare disease","quality of life","effectiveness","post-marketing requirement","safety","motor function","muscular dystrophy","standard of care","real-world evidence","observational study","post-marketing study","RECRUITING","2026-07-01",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2025-10-23",{"date":53,"type":21},"2030-07-30",{"name":55,"class":56},"ITF Therapeutics LLC","INDUSTRY",9,""]