[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epileptic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epileptic-encephalopathy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,81,108,131,157],{"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":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100594475","phase-3-a-clinical-trial-of-elsunersen-in-pediatric-scn2a-dee-to-assess-efficacy-and-safety-100594475","NCT07019922","A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety","A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy","Inclusion Criteria:\n\n* Has a documented Gain of Function SCN2A variant confirmed through genetic testing.\n* Has onset of seizures prior to 3 months of age.\n* Seizure frequency of 4 or more countable motor seizures per 28-day during the Baseline Observation Period.\n\nExclusion Criteria:\n\n* Has any clinically significant or known pathogenic genetic variant other than in the SCN2A gene, or a genetic variant that may explain or contribute to the participant's epilepsy and\u002For developmental disorder.\n* Has bone, spine (eg, kyphosis, scoliosis), bleeding, or other disorder.\n* Has received any experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, including any prior use of gene therapy.\n* Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial.","1 Day","18 Years",{"count":20,"type":21},"INTERVENTIONAL",[59],"PHASE3","A Multi-Center, Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Elsunersen in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy",[25,62],"SCN2A Encephalopathy",[64,65,66,67,68,69],"epilepsis","early onset scn2a","epileptic encephalopathy","scn2a","gain of function","seizure","RECRUITING","2026-05-22",{"date":35,"type":38},{"date":74,"type":38},"2025-08-13",{"date":76,"type":21},"2028-12",{"name":78,"class":79},"Praxis Precision Medicines","INDUSTRY",10,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":57,"phases":93,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100610459","phase-1-a-first-in-human-study-of-s230815-in-pediatric-participants-with-kcnt1-related-developmental-and-epileptic-encephalopathy-100610459","NCT07227857","A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy","A Phase Ib\u002FII First-in-human, Multicentre, Open-label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effect of Intrathecal S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy","KANDLE","Inclusion Criteria:\n\n* Male or female pediatric participants aged 2-12 years old at screening, with a genetically confirmed diagnosis of Developmental Epileptic Encephalopathy (DEE) due to a pathogenic or likely pathogenic variant in KCNT1 confirmed by central genetic testing.\n* Stable dose of other regular medications and\u002For stable antiseizure interventions (such as ketogenic diet and vagal nerve stimulation).\n\nExclusion Criteria:\n\n* Other clinical phenotypes associated with pathogenic or likely pathogenic variants in KCNT1 other than Epilepsy of Infancy with Migrating Focal Seizures or Early-Onset Epileptic Encephalopathy\n* Documented pathogenic or likely pathogenic variants in any other gene known to cause epilepsy identified through prior genetic testing. Variants of uncertain significance in other genes known to cause epilepsy may be considered on discussion with the sponsor.\n* Clinically significant medical history or clinical findings on physical examination, other than DEE, that in the judgment of the investigator, make the participant unsuitable for participation in the study and\u002For completion of the trial procedures, including, but not limited to:\n\n  * Clinically significant prior or ongoing medical conditions within 30 days of the screening visit, as per investigator judgement.\n  * Clinically significant abnormality on Electrocardiogram (ECG) at the screening visit, as per investigator judgement.\n  * Clinically significant abnormality on laboratory testing at screening, including, but not limited to:\n  * Renal insufficiency, which is defined as creatinine clearance \\\u003C 40 mL\u002Fmin assessed as estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula\n  * Hepatic derangement defined as transaminase values more than 3 times the Upper Limit of Normal (ULN) range, or total bilirubin values more than 1.5 times the ULN.\n* Positive hepatitis B surface antigen test, positive hepatitis C antibody test, positive for human immunodeficiency virus (HIV), as reported by a laboratory test within 6 months prior to the screening visit, or on screening bloods.\n* Bone, spine, bleeding disorders, or other disorder that exposes the participant to risk of injury or unsuccessful Lumbar puncture (e.g., haemophilia, Von Willebrand's disease, liver disease).\n* Contraindications to undergoing Magnetic Resonance Imaging (MRI), Lumbar puncture procedure and Intrathecal administration.\n* History of Central Nervous System (CNS) tumors or malignancies, including CNS metastatic disease.\n* Continuous respiratory support, defined as oxygen supplementation or non-invasive ventilation (e.g.: continuous positive airway pressure, bi-level intermittent positive airway pressure), required during waking hours. This does not include suctioning; cough assist devices or other devices that may be used regularly to clear airways.\n* Invasive ventilation including the presence of a tracheostomy.\n* Use of quinidine within 30 days prior to the screening visit.\n* Current use or anticipated use of antiplatelet or anticoagulant therapy during the study.\n* Current or past enrolment in an interventional clinical study in which an investigational therapy is\u002Fwas administered within 30 days (or 5 half-lives of study agent, whichever is longer) prior to the screening visit.\n* Implantable CNS device that may interfere with the ability to administer the study drug via Lumbar puncture.\n* Known hypersensitivity to any oligonucleotide, as demonstrated by a systemic allergic reaction (e.g., changes in pulse, blood pressure, breathing function, etc.), or any other drug that in the opinion of the investigator may preclude study participation.","2 Years","12 Years",{"count":92,"type":21},20,[94,95],"PHASE1","PHASE2","Study CL1-230815-001 (KANDLE) is a Phase Ib\u002FII, First In Human, multicentre, open-label, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effect of S230815 in pediatric participants with KCNT1-related Developmental Epileptic Encephalopathy. To participate in the study, participants must have a diagnosis of Developmental Epileptic Encephalopathy due to a documented pathogenic or likely pathogenic variant in KCNT1 (to be confirmed by central genetic testing at the screening visit). The study consists of a screening period followed by two consecutive interventional parts. Part 1 will evaluate multiple ascending doses of S230815. Part 2 is a long-term treatment extension for participants who have completed Part 1. Participants will seamlessly roll-over from Part 1 to Part 2, resuming the same cohort as they were assigned in Part 1, and will receive S230815 for a maximum of 72 weeks.",[25],"2026-05-21",{"date":100,"type":38},"2026-05-26",{"date":102,"type":38},"2025-11-24",{"date":104,"type":21},"2028-04-15",{"name":106,"class":45},"Institut de Recherches Internationales Servier",16,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100198356","genetics-of-epilepsy-and-related-disorders-100198356","NCT01858285","Genetics of Epilepsy and Related Disorders","inclusion: diagnosis of epilepsy, patient at Boston Children's Hospital exclusion: existing genetic diagnosis or known cause for epilepsy, structural malformation of the brain, not seen at Boston Children's Hospital",{"count":115,"type":21},5000,"Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to epilepsy and related disorders. These findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.",[118,25],"Epilepsy",[118,120],"Genetic","2026-01-07",{"date":123,"type":38},"2026-01-09",{"date":125,"type":4},"2010-11",{"date":127,"type":21},"2030-12",{"name":129,"class":45},"Boston Children's Hospital",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":138,"targetDuration":140,"studyType":22,"phases":4,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100424072","creation-of-a-register-of-patients-with-neonatal-onset-epileptic-encephalopathy-100424072","NCT04802135","Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy","IMPROVE","Inclusion Criteria:\n\n* Epilepsy beginning before 1 month of life, and requiring the initiation of anti-epileptic treatment\n* Without occasional cause\n* Without brain malformation explaining epilepsy\n* No opposition from parents \u002F guardians\n* Possibility for parents to complete parent questionnaires\n\nExclusion Criteria:\n\n* Neonatal attacks of occasional cause (glycemic disorder, infection, etc.)\n* Acquired neonatal epilepsy (post-anoxic encephalopathy, stroke sequelae, etc.)\n* Neonatal epilepsy related to a brain malformation",{"count":139,"type":21},200,"3 Years","Electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (EOEE). EOEE are rare and severe epileptic syndromes characterized by epilepsy that begins within the first three months of life and is associated with rapid deterioration of motor, cognitive and behavioral skills.\n\nThere is a genetic basis for the EOEE. Together with other laboratories, the investigators have identified de novo pathogenic variants in the KCNQ2 gene encoding the Kv7.2 subunit of the Kv7 \u002F M potassium channel, a channel known to control neuronal excitability in the brain and spinal cord. via the current M (IM). Pathogenic variants of the KCNQ2 gene represent the main cause of EOEE and the term KCNQ2-related epileptic encephalopathy (KCNQ2-REE) is now used to define this condition.\n\nKCNQ2-REE patients have a remarkably homogeneous phenotype at the start, with epilepsy that begins in the first days after birth, seizures that result in tonic muscle spasms that last from 1 to 10 seconds, and an interictal EEG called \"suppression-burst\". \"That is, paroxysmal bursts of activity interspersed with periods of electrical silence. In this group, more than 50% of the patients present a remission of the epilepsy and a quasi-normalization of the EEG which can occur a few weeks to several months after the onset of the seizures. Despite this positive evolution in terms of seizures, the developmental progression is abnormal and the phenotype is severe with an absence of language, autistic behavior and a subsequent development of motor disorders such as diplegia, spasticity, ataxia or dystonia.\n\nThe ambition of this project is to increase knowledge of epileptic encephalopathies linked to KCNQ2 at the clinical and molecular levels, to decipher the pathophysiological mechanisms and to propose therapeutic strategies.\n\nThis project aims to better describe the clinical, EEG, imaging, developmental and long-term follow-up characteristics of patients carrying the KCNQ2 mutation identified in the laboratory.",[25],[144,145,146],"EOEE","epilepsy","KCNQ2","2025-11-17",{"date":149,"type":38},"2025-11-20",{"date":151,"type":38},"2021-03-06",{"date":153,"type":21},"2032-09",{"name":155,"class":45},"Assistance Publique Hopitaux De Marseille",15,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":57,"phases":167,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100581868","home-ultra-long-term-eeg-monitoring-for-rare-epilepsies-and-developmental-and-epileptic-encephalopathies-100581868","NCT06855901","Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies","Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device","EMIRE","Inclusion Criteria:\n\n* Age \\> 12 years old, with or without intellectual disabilities;\n* Diagnosis of drug resistant seizures, DEE or rare epilepsies ;\n* One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;\n* Availability for the duration of the study (3 months);\n\nExclusion Criteria:\n\n* Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;\n* Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;\n* Subject has an infection at implant site;\n* Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;\n* Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));\n* Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;\n* Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;\n* Subject is unable or does not have the necessary assistance to properly operate the device system.\n* Pregnancy",{"count":166,"type":21},30,[168],"NA","With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).\n\nThe following aims will be pursued:\n\n1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;\n2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure\u002Finterictal epileptic discharges; distribution for the development of personalized seizure action plan;\n3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.\n\nThe investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.\n\nThe potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.",[171,172,25],"Epilepsies","Epilepsies, Focal",[118,174,175,176],"Epileptic encephalopathies","subscalp EEG","Ultra-long EEG monitoring","2025-02-27",{"date":179,"type":38},"2025-03-04",{"date":181,"type":38},"2024-01-17",{"date":183,"type":21},"2026-12-30",{"name":185,"class":45},"Azienda Ospedaliero-Universitaria di Modena",4]