[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"developmental-and-epileptic-encephalopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:developmental-and-epileptic-encephalopathies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100638796","ibis---investigating-reliability-of-bis-and-sedline-monitoring-in-children-with-developmental-and-epileptic-encephalopathies-dee-100638796",false,"NCT07585643","IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).","IBIS","Inclusion Criteria:\n\n* Children (\\\u003C16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).\n\nExclusion Criteria:\n\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in the care of the child.","ALL","0 Years","15 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.\n\nChildren with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.",[25,26,27,28],"Epileptic Encephalopathy","Early Infantile Epileptic Encephalopathy","Infantile Spasm","Developmental and Epileptic Encephalopathies",[30,31,32,33],"epileptic encepthalopathy","anaesthesia","PILOT STUDY","MULTICENTRE","NOT_YET_RECRUITING","2026-05-27",{"date":37,"type":38},"2026-05-29","ACTUAL",{"date":40,"type":21},"2026-05-20",{"date":42,"type":21},"2029-06-20",{"name":44,"class":45},"Telethon Kids Institute","OTHER",2,{"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":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100569943","phase-1-ketogenic-diet-for-prevention-of-epileptic-spasms-in-infantile-onset-genetic-epilepsies-100569943","NCT06700811","Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies","Phase 1 Study of Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies","Inclusion Criteria:\n\n* Plan for initiation of ketogenic diet by clinical team for treatment of epilepsy\n* The clinical team initiating the ketogenic diet agrees that the use of the KetoVie formula is appropriate for the subject, as all study subjects need to receive the same formula\n* Male or female, age 0 to less than 9 months (including neonates per investigator's judgment)\n* Epilepsy onset at less than 6 months of age\n* Abnormal development (any sub score of the Bayley-4 less than 1 standard deviation below the mean) and\u002For neurologic exam (microcephaly, macrocephaly, strabismus, abnormal vision\u002FCVI, hypotonia, spasticity, dystonia, movement disorder), per investigators judgment\n* Genetic epilepsy diagnosis, pathogenic or likely pathogenic variant(s) with consistent phenotype and inheritance pattern\n* Weight adequate to complete required study laboratory testing without exceeding maximum allowable blood draws per draw or in a 30 day period per BCH policy\n\nExclusion Criteria:\n\n* Epileptic spams prior to enrollment\n* Tuberous sclerosis complex, trisomy 21 (based on differential response to ES treatment)\n* Metabolic diagnosis with targeted treatment (including specific indication for ketogenic diet such as glucose transporter disorder, vitamin dependent epilepsies, and others) or exclusion for the ketogenic diet\n* Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide. Other anti-seizure medications are permitted.","0 Days","9 Months",{"count":57,"type":21},10,"INTERVENTIONAL",[60],"PHASE1","Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate\u002Fprotein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.",[28,63,64,65],"Epileptic Spasms","Genetic Epilepsy","Neonatal and Infant Epilepsy",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"Ketogenic diet","Epileptic spasms prevention","epilepsy","infantile spasms","epileptic spasms","seizures","infant","eeg","open label","Phase 1","dietary treatments","developmental and epileptic encephalopathy","genetic","prevention","epileptic encephalopathy","refractory epilepsy","RECRUITING","2026-01-29",{"date":86,"type":38},"2026-02-02",{"date":88,"type":38},"2025-08-11",{"date":90,"type":21},"2028-05",{"name":92,"class":45},"Heather Olson",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":102,"enrollmentInfo":4,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":116,"locationsCount":119},"100527584","intermediate-size-expanded-access-protocol-eap-for-lp352-100527584","NCT06149663","Intermediate-Size Expanded Access Protocol (EAP) for LP352","Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)","Inclusion Criteria:\n\n1. Participant and\u002For participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (\\\u003C18 years of age) as required by local regulations.\n2. Participant with DEE who has successfully completed an LP352 Clinical Trial.\n3. Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.\n4. Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.\n\nExclusion Criteria:\n\n1. Participant was discontinued from an LP352 Clinical Trial for any reason.\n2. Any serious and\u002For unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.","2 Years","65 Years","EXPANDED_ACCESS","This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.",[106,107,28],"Dravet Syndrome","Lennox Gastaut Syndrome",[109,78,106,69,107,110,111],"CDKL5 deficiency disorder","treatment resistant epilepsy","tuberous sclerosis complex","AVAILABLE","2025-01-20",{"date":115,"type":38},"2025-01-22",{"name":117,"class":118},"Longboard Pharmaceuticals","INDUSTRY",22]