[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"developmental-and-epileptic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:developmental-and-epileptic-encephalopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,89],{"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":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100571352","phase-3-a-study-to-investigate-lp352-in-children-and-adults-with-developmental-and-epileptic-encephalopathies-dee-100571352",false,"NCT06719141","A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies","Inclusion Criteria:\n\n* Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:\n\n  * Onset of seizures at ≤8 years old\n  * History of tonic\u002Ftonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms\n  * Presence of developmental plateauing or regression\n  * History of electroencephalogram (EEG) showing generalized slow (\\\u003C2.5 Hertz \\[Hz\\]) spike-and-wave complexes\n* Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:\n\n  * Does not meet criteria for LGS\n  * Onset of seizures at ≤5 years old\n  * Presence of developmental plateauing or regression\n  * History of multiple seizure types\n  * History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)\n* The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal\u002Fleg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic.\n* The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening.\n* The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.\n* The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.\n* The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative.\n\nExclusion Criteria:\n\n* The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.\n* The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.\n* The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.\n* The participant has an acquired lesion\u002Finjury unrelated to the primary etiology that could contribute as a secondary cause of seizures.\n* The participant is receiving exclusionary medications.\n* The participant is currently using any cannabis product or cannabidiol that is not in oral solution\u002Fcapsule\u002Ftablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).\n* The participant has unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension\u002Ftachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.\n* The participant is unable or unwilling to comply with any of the study requirements or timelines.","ALL","2 Years","65 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.",[27],"Developmental and Epileptic Encephalopathy",[29,30,31,32,33,34,35,36,37],"Developmental and epileptic encephalopathy","LP352","Seizures","Bexicaserin","Antiseizure medications (ASMs)","Epilepsy","Lennox-Gastaut Syndrome (LGS)","Neurodevelopmental disorders","DEEp OCEAN","RECRUITING","2026-06-11",{"date":41,"type":42},"2026-06-12","ACTUAL",{"date":44,"type":42},"2024-11-11",{"date":46,"type":21},"2026-11-30",{"name":48,"class":49},"Longboard Pharmaceuticals","INDUSTRY",114,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100623457","developmental-and-epileptic-encephalopathies-diagnosed-via-long-read-genome-sequencing-100623457","NCT07396883","Developmental and Epileptic Encephalopathies Diagnosed Via Long-read Genome Sequencing","Developmental and Epileptic Encephalopathies Diagnosed Via Long-read Genome Sequencing - EEPILOG","EEPILOG","Inclusion Criteria:\n\nPediatric Participants:\n\n* Age \\\u003C 18 years.\n* Diagnosis of Developmental and Epileptic Encephalopathy (DEE) according to 2022 ILAE criteria (severe epilepsy, encephalopathic EEG, multiple drug-resistant seizures, and neurodevelopmental disorder).\n* Brain MRI without markers of perinatal anoxia.\n* Negative molecular diagnosis after short-read Whole Genome Sequencing (srWGS) via the French Genomic Medicine Plan 2025 (AURAGEN).\n* Available banked DNA at a participating center.\n\nParents\u002FLegal Guardians:\n\n* Age ≥ 18 years.\n* Able to understand study objectives and risks.\n* Signed and dated informed consent.\n* Affiliated with or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\nPediatric Participants:\n\n* Brain MRI findings in favor of perinatal cerebral anoxia.\n* Intercurrent diseases preventing the completion of protocol examinations.\n* Subject currently in an exclusion period from another study.\n\nParents\u002FLegal Guardians:\n\n* Inability to receive or understand informed information (e.g., life-threatening emergency).\n* Subject under judicial protection, tutelage, or curatorship.\n* Language barriers where an official interpreter is unavailable.","18 Years",{"count":61,"type":21},20,"OBSERVATIONAL","This study focuses on children with Developmental and Epileptic Encephalopathy (DEE), a severe form of epilepsy that often has a genetic origin. Currently, standard diagnostic tools-known as short-read genome sequencing-fail to provide a diagnosis for over 50% of affected patients because they cannot detect certain complex DNA abnormalities.\n\nThe purpose of this study is to evaluate the effectiveness of a newer, more advanced technology called Long-read Genome Sequencing (lrWGS). Unlike traditional methods, this technology analyzes very long fragments of DNA, allowing researchers to identify genetic errors that were previously \"invisible.\"\n\nThe study aims to answer whether Long-read Sequencing can successfully identify the genetic cause of epilepsy in patients who have already received a negative result from standard testing. By finding these missing answers, the research seeks to enable personalized medical treatments, improve genetic counseling for families, and advance our understanding of how these complex neurological conditions develop.",[27,65],"Epilepsy in Children",[67,68,69,70,71,72,73,74,75,76],"Developmental and Epileptic Encephalopathy (DEE)","Drug-Resistant Epilepsy","Long-read Whole Genome Sequencing (lrWGS)","Long-read Sequencing","Negative Short-read Sequencing","Genetic Diagnosis","Pediatric Neurology","High-Throughput Nucleotide Sequencing","Early-Onset Epilepsy","Genetic Epilepsy","NOT_YET_RECRUITING","2026-02-02",{"date":80,"type":42},"2026-02-09",{"date":82,"type":21},"2026-06",{"date":84,"type":21},"2028-06",{"name":86,"class":87},"University Hospital, Strasbourg, France","OTHER",4,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100545306","developmental-and-epileptic-encephalopathy-of-genetic-etiology-natural-history-through-reuse-of-clinical-data-100545306","NCT06380192","Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data","Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data \u002F DEE-RETRO","DEE-RETRO","Inclusion Criteria:\n\n* Diagnosis of Developmental and Epileptic Encephalopathy\n* Registered with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Opposition of the patient or his\u002Fher parents to the re-use of data in the context of this study\n* Person subject to a safeguard of justice measure",{"count":98,"type":21},400,"Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.\n\nThe creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.",[27],"2025-06-25",{"date":103,"type":42},"2025-06-29",{"date":105,"type":42},"2024-10-31",{"date":107,"type":21},"2026-12-31",{"name":109,"class":87},"Imagine Institute",23]