[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602781":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":15,"responsibleParty":175,"collaborators":10,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":179,"sex":185,"minAge":186,"maxAge":10,"enrollmentInfo":187,"targetDuration":10,"studyType":190,"phases":10,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":18,"whyStopped":10,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"fullName":5,"class":6},"ITF Therapeutics LLC","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Ambulatory",null,"Ambulatory is defined as being able to complete the 10-meter Walk-Run (10mWR) test within 30 seconds without an assistive device.\n\nThis cohort will include up to 120 patients who are ambulatory prior to starting givinostat treatment.\n\nWithin this cohort , 95 patients must have had prior use or a referral for concomitant use of dystrophin-enhancing therapy (DET), such as exon skipping oligonucleotides or gene therapy.\n\nEnrollment is capped at 25 patients without prior or referred DET use.",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-Ambulatory","Non-ambulatory status is determined by inability to perform the 10mWR test as defined above.\n\nThis cohort will include approximately 180 patients who are non-ambulatory prior to starting givinostat.",[16,39,56,73,90,108,124,141,158],{"facility":17,"status":18,"city":19,"state":20,"zip":21,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"Arkansas Children's Research Institute","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":25,"coordinates":26},"Point",[27,28],-92.28959,34.74648,{"lat":28,"lon":27},[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Domencia Hunter","CONTACT","973-932-9211","hunterdj@archildrens.org",{"name":37,"role":38,"phone":10,"phoneExt":10,"email":10},"Aravindhan Veerapandiyan","PRINCIPAL_INVESTIGATOR",{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":22,"countryCode":23,"cosmosGeoPoint":44,"geoPoint":48,"contacts":49},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":25,"coordinates":45},[46,47],-77.03637,38.89511,{"lat":47,"lon":46},[50,54],{"name":51,"role":33,"phone":52,"phoneExt":10,"email":53},"Margaret Martinez","202-476-2431","mbmartin@childrensnational.org",{"name":55,"role":38,"phone":10,"phoneExt":10,"email":10},"Sarah Wright, DO",{"facility":57,"status":18,"city":58,"state":59,"zip":60,"country":22,"countryCode":23,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Ann and Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":25,"coordinates":62},[63,64],-87.65005,41.85003,{"lat":64,"lon":63},[67,71],{"name":68,"role":33,"phone":69,"phoneExt":10,"email":70},"Raven Hill","312-227-2937","rhill@luriechildrens.org",{"name":72,"role":38,"phone":10,"phoneExt":10,"email":10},"Bridget McGowan",{"facility":74,"status":18,"city":75,"state":76,"zip":77,"country":22,"countryCode":23,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":25,"coordinates":79},[80,81],-71.05977,42.35843,{"lat":81,"lon":80},[84,88],{"name":85,"role":33,"phone":86,"phoneExt":10,"email":87},"Gerald Mastellone","857-218-4677","Gerald.mastellone@childrens.harvard.edu",{"name":89,"role":38,"phone":10,"phoneExt":10,"email":10},"Partha Ghosh, MD",{"facility":91,"status":18,"city":92,"state":76,"zip":93,"country":22,"countryCode":23,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Massachusetts Chan Medical School","Worcester","01655",{"type":25,"coordinates":95},[96,97],-71.80229,42.26259,{"lat":97,"lon":96},[100,104,106],{"name":101,"role":33,"phone":102,"phoneExt":10,"email":103},"Sarah Figueira","(508) 856-1604","sarah.figueira@umassmed.edu",{"name":10,"role":33,"phone":10,"phoneExt":10,"email":105},"dmdprogram@umassmemorial.org",{"name":107,"role":38,"phone":10,"phoneExt":10,"email":10},"Stephen Chrzanowski",{"facility":109,"status":18,"city":110,"state":110,"zip":111,"country":22,"countryCode":23,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Columbia University Medical Center","New York","10032",{"type":25,"coordinates":113},[114,115],-74.00597,40.71427,{"lat":115,"lon":114},[118,122],{"name":119,"role":33,"phone":120,"phoneExt":10,"email":121},"Kimberly Berry","212-342-3038","kb2996@cumc.columbia.edu",{"name":123,"role":38,"phone":10,"phoneExt":10,"email":10},"Divya Jayaraman",{"facility":125,"status":18,"city":126,"state":127,"zip":128,"country":22,"countryCode":23,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Duke University \u002F Lenox Baker Children's Hospital","Durham","North Carolina","27705",{"type":25,"coordinates":130},[131,132],-78.89862,35.99403,{"lat":132,"lon":131},[135,139],{"name":136,"role":33,"phone":137,"phoneExt":10,"email":138},"Brittany Nave","919-684-8087","brittany.nave@duke.edu",{"name":140,"role":38,"phone":10,"phoneExt":10,"email":10},"Natalie Katz, MD",{"facility":142,"status":18,"city":143,"state":144,"zip":145,"country":22,"countryCode":23,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Oregon Health and Science University","Portland","Oregon","97239",{"type":25,"coordinates":147},[148,149],-122.67621,45.52345,{"lat":149,"lon":148},[152,156],{"name":153,"role":33,"phone":154,"phoneExt":10,"email":155},"Nadee Dayananda","503-418-0949","dayanand@ohsu.edu",{"name":157,"role":38,"phone":10,"phoneExt":10,"email":10},"Erika Finanger, MD",{"facility":159,"status":18,"city":160,"state":161,"zip":162,"country":22,"countryCode":23,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":25,"coordinates":164},[165,166],-122.33207,47.60621,{"lat":166,"lon":165},[169,173],{"name":170,"role":33,"phone":171,"phoneExt":10,"email":172},"Macarena Racciatti","206-995-6847","macarena.racciatti@seattlechildrens.org",{"name":174,"role":38,"phone":10,"phoneExt":10,"email":10},"Alicia Henriquez",{"type":176,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":188,"type":189},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.",[193],"Duchene Muscular Dystrophy",[195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212],"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","2026-07-01",{"date":215,"type":216},"2026-07-02","ACTUAL",{"date":218,"type":216},"2025-10-23",{"date":220,"type":189},"2030-07-30",{"name":5,"class":6},9]