[{"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:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"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":19,"type":20},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.",[24],"Duchene Muscular Dystrophy",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"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":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2025-10-23",{"date":52,"type":20},"2030-07-30",{"name":54,"class":55},"ITF Therapeutics LLC","INDUSTRY",9,""]