[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"absence-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:absence-epilepsy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Absence Epilepsy","Ketogenic Dieting","Epilepsy, Absence",[31,32,33],"ketogenic","diet","absence","RECRUITING","2026-05-05",{"date":37,"type":38},"2026-05-07","ACTUAL",{"date":40,"type":38},"2020-08-10",{"date":42,"type":21},"2028-05-01",{"name":44,"class":45},"Johns Hopkins University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100546943","phase-2-bmb-101-in-absence-epilepsy-and-dee-100546943","NCT06401538","BMB-101 in Absence Epilepsy and DEE","An Open-Label Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of BMB-101 in Adults With Either Classic Absence Epilepsy (With or Without Eyelid Myoclonia (EEM; Jeavons Syndrome), OR Developmental Epileptic Encephalopathy (DEE).","Inclusion Criteria:\n\n1. Subjects must have a diagnosis of Absence Epilepsy with or without eyelid myoclonia (Jeavons Syndrome) or a diagnosis of Developmental and Epileptic Encephalopathy (DEE) such as Dravet syndrome or Lennox-Gastaut syndrome or other DEE.\n2. Subjects with Absence must experience at least 4 episodes of 3-4\u002Fsecond SWD lasting at least 3 seconds each in a 24 hour EEG during the baseline period. Those with DEE must have a typical EEG pattern for DEE on routine EEG and experience at least 4 seizures during the 4 week baseline period prior to BMB-101 administration.\n3. Subjects can be male or female ages 18-65 inclusive at time of baseline.\n4. Subject must have tried at least one anti-seizure medication at a recommended dose and duration and must be on a stable dose on their current anti-seizure medications for at least 4 weeks prior to baseline and remain stable throughout the study.\n5. Subjectis willing and able to be compliant with diary completion, visit schedule, and study drug accountability.\n6. Female subjects of childbearing potential must have a negative urine pregnancy test at baseline. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while in this study and for 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Subject has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, pulmonary hypertension, myocardial infarction or stroke, or clinically significant structural cardiac abnormality.\n2. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes \\\u003C 3x upper limit of normal (ULN) and\u002For elevated bilirubin \\\u003C2x ULN) may be entered into the study after review and approval by the Medical Monitor in conjunction with the sponsor, in consideration of comorbidities and concomitant medications.\n3. Subject has severe renal impairment (estimated glomerular filtration rate \\\u003C30mL\u002Fmin\u002F1.73m2)\n4. Clinically significant ECG abnormality such as QTcF \\>450 msec (males) or \\>470 msec (females)\n5. Subject is receiving concomitant therapy with: fenfluramine, lorcaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics).\n6. Subject is currently receiving an investigational medicinal product.\n7. Subject has participated in another clinical trial within the past 30 days (calculated from that study's last scheduled visit). Participation in non-treatment trials will be reviewed by the medical monitor.\n8. Subject has a history of drug or alcohol abuse within the last 12 months or a positive urine drug screen (with the exception of cannabinoids).\n9. A current C-SSRS score of 4 or 5 at baseline or history of suicide attempt at any time during the past year\n10. Subject has a clinically significant condition or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Baseline Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.","18 Years","65 Years",{"count":57,"type":21},20,[59],"PHASE2","The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Absence Epilepsy including Epilepsy with Eyelid Myoclonia (also called Jeavons Syndrome) as well as Developmental Epileptic Encephalopathies such as Dravet and Lennox Gastaut. The study will last up to 6 months. There will be a 1 month screening period, then up to 3 months on open-label BMB-101 including titration and tapering\u002Fwashout periods, and then a 1 month follow-up period. There will be 6 clinic visits.",[27,62,63,64],"Jeavons Syndrome","Dravet Syndrome","Lennox Gastaut Syndrome","2025-08-07",{"date":67,"type":38},"2025-08-12",{"date":69,"type":38},"2024-12-05",{"date":71,"type":21},"2025-11-30",{"name":73,"class":74},"Bright Minds Biosciences Pty Ltd","INDUSTRY",5]