[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551865":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylphenidate","ACTIVE_COMPARATOR","Methylphenidate hydrochloride in capsules",[13],"Drug: Methylphenidate Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Microcrystalline cellulose in capsules",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Methylphenidate Hydrochloride",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Charlotte Ockeloen, MD","CONTACT","+31243613946","charlotte.ockeloen@radboudumc.nl",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Nijmegen","Gelderland","6500 HB","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],5.85278,51.8425,{"lat":46,"lon":45},[49],{"name":30,"role":31,"phone":25,"phoneExt":25,"email":33},{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100551865","phase-4-methylphenidate-in-kbg-syndrome-n-of-1-series-100551865",false,"NCT06465641","Methylphenidate in KBG Syndrome: N-of-1 Series","Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series","KBGS_N_of_1","Inclusion Criteria:\n\n* Age 6-20 years\n* Molecularly confirmed diagnosis of KBG syndrome (pathogenic ANKRD11 variant or a chromosome 16q24 deletion including ANKRD11)\n* Attention deficit or ADHD-related symptoms or a formal ADHD diagnosis, with a significant impact on daily life\\*\n* Presence of a subject's caregiver or supervisor for proxy-reports\n\nExclusion Criteria:\n\n* Family history of acute cardiac death that warrants further cardiac investigation\n* Cardiovascular disease in medical history (severe hypertension, heart failure, arterial occlusive disease, potentially life-threatening arrythmias, angina pectoris, hemodynamically significant congenital heart defect, cardiomyopathy, myocardial infarction and channelopathy)\n* Current or previous presence of hyperthyroidism, glaucoma or pheochromocytoma\n* Use of (psychotropic\u002Fstimulant) drugs which interact with MPH\n* Schizophrenic or psychotic disorder in medical history\n* Unstable epilepsy (not controlled with medication)\n* History of frequent drug and\u002For alcohol abuse\n* Excessive alcohol\u002Fdrug use and\u002For intoxication with one or both during the study\n* Pregnant or lactating women\n* Inability to understand or speak Dutch","ALL","6 Years","20 Years",{"count":64,"type":65},15,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","The goal of this clinical trial\\] is to learn about the effect of methylphenidate in children and adolescents with KBG syndrome. The main question it aims to answer is:\n\n• What is the effectiveness of methylphenidate on attention deficit and ADHD-related symptoms in children and adolescents with KBG syndrome?\n\nParticipants will receive multiple blocks of treatment with methylphenidate and placebo and fill out various questionnaires.",[71,72],"Kbg Syndrome","ADHD - Combined Type","2024-12-24",{"date":75,"type":76},"2024-12-27","ACTUAL",{"date":78,"type":76},"2024-11-13",{"date":80,"type":65},"2027-10-01",{"name":5,"class":6},1]