[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602781":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":15,"responsibleParty":174,"collaborators":10,"id":176,"slug":10,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":10,"enrollmentInfo":185,"targetDuration":10,"studyType":188,"phases":10,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":18,"whyStopped":10,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"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.",[16,38,55,72,89,107,123,140,157],{"facility":17,"status":18,"city":19,"state":20,"zip":21,"country":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"Arkansas Children's Research Institute","RECRUITING","Little Rock","Arkansas","72202","United States",{"type":24,"coordinates":25},"Point",[26,27],-92.28959,34.74648,{"lat":27,"lon":26},[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Domencia Hunter","CONTACT","973-932-9211","hunterdj@archildrens.org",{"name":36,"role":37,"phone":10,"phoneExt":10,"email":10},"Aravindhan Veerapandiyan","PRINCIPAL_INVESTIGATOR",{"facility":39,"status":18,"city":40,"state":41,"zip":42,"country":22,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":24,"coordinates":44},[45,46],-77.03637,38.89511,{"lat":46,"lon":45},[49,53],{"name":50,"role":32,"phone":51,"phoneExt":10,"email":52},"Margaret Martinez","202-476-2431","mbmartin@childrensnational.org",{"name":54,"role":37,"phone":10,"phoneExt":10,"email":10},"Sarah Wright, DO",{"facility":56,"status":18,"city":57,"state":58,"zip":59,"country":22,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Ann and Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":24,"coordinates":61},[62,63],-87.65005,41.85003,{"lat":63,"lon":62},[66,70],{"name":67,"role":32,"phone":68,"phoneExt":10,"email":69},"Raven Hill","312-227-2937","rhill@luriechildrens.org",{"name":71,"role":37,"phone":10,"phoneExt":10,"email":10},"Bridget McGowan",{"facility":73,"status":18,"city":74,"state":75,"zip":76,"country":22,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":24,"coordinates":78},[79,80],-71.05977,42.35843,{"lat":80,"lon":79},[83,87],{"name":84,"role":32,"phone":85,"phoneExt":10,"email":86},"Gerald Mastellone","857-218-4677","Gerald.mastellone@childrens.harvard.edu",{"name":88,"role":37,"phone":10,"phoneExt":10,"email":10},"Partha Ghosh, MD",{"facility":90,"status":18,"city":91,"state":75,"zip":92,"country":22,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of Massachusetts Chan Medical School","Worcester","01655",{"type":24,"coordinates":94},[95,96],-71.80229,42.26259,{"lat":96,"lon":95},[99,103,105],{"name":100,"role":32,"phone":101,"phoneExt":10,"email":102},"Sarah Figueira","(508) 856-1604","sarah.figueira@umassmed.edu",{"name":10,"role":32,"phone":10,"phoneExt":10,"email":104},"dmdprogram@umassmemorial.org",{"name":106,"role":37,"phone":10,"phoneExt":10,"email":10},"Stephen Chrzanowski",{"facility":108,"status":18,"city":109,"state":109,"zip":110,"country":22,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Columbia University Medical Center","New York","10032",{"type":24,"coordinates":112},[113,114],-74.00597,40.71427,{"lat":114,"lon":113},[117,121],{"name":118,"role":32,"phone":119,"phoneExt":10,"email":120},"Kimberly Berry","212-342-3038","kb2996@cumc.columbia.edu",{"name":122,"role":37,"phone":10,"phoneExt":10,"email":10},"Divya Jayaraman",{"facility":124,"status":18,"city":125,"state":126,"zip":127,"country":22,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Duke University \u002F Lenox Baker Children's Hospital","Durham","North Carolina","27705",{"type":24,"coordinates":129},[130,131],-78.89862,35.99403,{"lat":131,"lon":130},[134,138],{"name":135,"role":32,"phone":136,"phoneExt":10,"email":137},"Brittany Nave","919-684-8087","brittany.nave@duke.edu",{"name":139,"role":37,"phone":10,"phoneExt":10,"email":10},"Natalie Katz, MD",{"facility":141,"status":18,"city":142,"state":143,"zip":144,"country":22,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Oregon Health and Science University","Portland","Oregon","97239",{"type":24,"coordinates":146},[147,148],-122.67621,45.52345,{"lat":148,"lon":147},[151,155],{"name":152,"role":32,"phone":153,"phoneExt":10,"email":154},"Nadee Dayananda","503-418-0949","dayanand@ohsu.edu",{"name":156,"role":37,"phone":10,"phoneExt":10,"email":10},"Erika Finanger, MD",{"facility":158,"status":18,"city":159,"state":160,"zip":161,"country":22,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":24,"coordinates":163},[164,165],-122.33207,47.60621,{"lat":165,"lon":164},[168,172],{"name":169,"role":32,"phone":170,"phoneExt":10,"email":171},"Macarena Racciatti","206-995-6847","macarena.racciatti@seattlechildrens.org",{"name":173,"role":37,"phone":10,"phoneExt":10,"email":10},"Alicia Henriquez",{"type":175,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":186,"type":187},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.",[191],"Duchene Muscular Dystrophy",[193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210],"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":213,"type":214},"2026-07-02","ACTUAL",{"date":216,"type":214},"2025-10-23",{"date":218,"type":187},"2030-07-30",{"name":5,"class":6},9]