[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Longboard Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,74],{"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":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100566839","phase-3-a-phase-3-placebo-controlled-study-to-investigate-lp352-in-children-and-adults-with-dravet-syndrome-ds-100566839","NCT06660394","A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)","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 Dravet Syndrome","Inclusion Criteria:\n\n* Diagnosis of DS must fulfill all of the following criteria:\n\n  1. Participants with seizure onset age \\>1 and \\\u003C20 months\n  2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus\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 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.\n\nExclusion Criteria:\n\n* The participant has a history of infantile\u002Fepileptic spasms.\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 unwilling to comply with any of the study requirements or timelines.",{"count":59,"type":21},160,[24],"This (DEEp SEA 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 DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.",[63],"Dravet Syndrome",[65,34,36,29,30,31,66,32],"Antiseizure medication","DEEp SEA",{"date":41,"type":42},{"date":69,"type":42},"2024-09-25",{"date":71,"type":21},"2026-10-02",{"name":48,"class":49},101,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":4,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":96,"locationsCount":97},"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.","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.",[63,84,85],"Lennox Gastaut Syndrome","Developmental and Epileptic Encephalopathies",[87,88,63,89,84,90,91],"CDKL5 deficiency disorder","developmental and epileptic encephalopathy","epilepsy","treatment resistant epilepsy","tuberous sclerosis complex","AVAILABLE","2025-01-20",{"date":95,"type":42},"2025-01-22",{"name":48,"class":49},22,""]