[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383555":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":76,"collaborators":25,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":25,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diet therapy","EXPERIMENTAL","Modified Atkins Diet - high fat, low carbohydrate, outpatient initiated approach. Parents will check urine ketones twice weekly and follow by email, phone and clinic. Labs at baseline and 3 months. Dietitian support.",[13],"Other: Modified Atkins Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Drug therapy","ACTIVE_COMPARATOR","Families will have the usual care for absence epilepsy at the discretion of the family's neurologist and the family choice. Typically ethosuximide bis in die (BID), however, if convulsions have occurred or other factors are involved, the child may be started on valproate or lamotrigine. The child will continue medications with dose adjustment and antiseizure drug levels checked as usual. \\*\\*OF NOTE, THIS ARM IS COMPLETED",[19],"Drug: Absence epilepsy medications",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Modified Atkins Diet","Low carb (20g\u002Fday), high fat, moderate protein diet. Started as an outpatient in clinic.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Absence epilepsy medications","At neurologist's discretion. \\*OF NOTE\\\u003C THIS ARM IS COMPLETED",[15],[32],"Ethosuximide, valproate or lamotrigine",[34],{"name":35,"affiliation":5,"role":36},"Eric H Kossoff, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","4109559100","ekossoff@jhmi.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-76.61219,39.29038,{"lat":55,"lon":54},[58,60,61,64,66,68,70,72,74],{"name":35,"role":39,"phone":59,"phoneExt":25,"email":41},"410-955-9100",{"name":35,"role":36,"phone":25,"phoneExt":25,"email":25},{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Zahava Turner, RD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":25,"phoneExt":25,"email":25},"Courtney Haney, RD",{"name":67,"role":63,"phone":25,"phoneExt":25,"email":25},"Eva Catenaccio, MD",{"name":69,"role":63,"phone":25,"phoneExt":25,"email":25},"Danielle DeCampo, MD",{"name":71,"role":63,"phone":25,"phoneExt":25,"email":25},"Rachel Penn, MD",{"name":73,"role":63,"phone":25,"phoneExt":25,"email":25},"Ania Dabrowski, MD",{"name":75,"role":63,"phone":25,"phoneExt":25,"email":25},"Lindsay Schleifer, MD",{"type":77,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100383555","phase-3-ketogenic-diet-for-new-onset-absence-epilepsy-100383555",false,"NCT04274179","Ketogenic Diet for New-Onset Absence Epilepsy","A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy","Inclusion Criteria:\n\n* Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.\n* Normal intellect or mild disability\n* EEG with confirmed 3\u002Fsecond spike-wave discharges, usually with hyperventilation\n* Daily reported absence seizures.\n* Generalized convulsions allowed\n\nExclusion Criteria:\n\n* Previous treatment with any anticonvulsant drug\n* Previous use of a ketogenic dietary therapy for epilepsy or any other condition\n* Glut1 deficiency syndrome\n* Metabolic disorder known that would preclude dietary therapy\n* Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.\n* Prior history of epilepsy (febrile seizures allowed)\n* Unwilling to consent to study procedures or return for visits","ALL","3 Years","12 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medications). Childhood absence epilepsy (refractory) has been published as being responsive to ketogenic diet therapy by the investigators' group previously. This is a small, prospective, 3 month trial to assess if using a modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy. The investigators will compare to a group of children in which the parents have declined and chose to start anticonvulsant medications.",[96,97,98],"Absence Epilepsy","Ketogenic Dieting","Epilepsy, Absence",[100,101,102],"ketogenic","diet","absence","2026-05-05",{"date":105,"type":106},"2026-05-07","ACTUAL",{"date":108,"type":106},"2020-08-10",{"date":110,"type":90},"2028-05-01",{"name":5,"class":6},1]