Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 5:39 AM
Study NCT ID:
NCT06660394
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline', 'timeFrame': 'Baseline and up to 15 Weeks', 'description': 'The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of LP352', 'timeFrame': 'Up to 21 Weeks', 'description': 'Safety and tolerability as measured by incidence and severity of non-serious Treatment Emergent Adverse Events (TEAEs), Serious Adverse events (SAEs), AEs leading to discontinuation and clinically significant changes in laboratory parameters (hematology, serum chemistry and Urinalysis), physical examination findings, vital signs, growth parameters (height and weight), 12-lead electrocardiograms (ECGs), C-SSRS responses, and PHQ-9 total score and Question 9 score.'}, {'measure': 'Percentage of participants with ≥ 50% Reduction in countable motor seizures during Treatment compared to Baseline', 'timeFrame': 'Baseline and up to 15 Weeks'}, {'measure': 'Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline', 'timeFrame': 'Baseline and up to 15 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antiseizure medication', 'Epilepsy', 'Neurodevelopmental disorders', 'Developmental and epileptic encephalopathy', 'LP352', 'Seizures', 'DEEp SEA', 'Bexicaserin'], 'conditions': ['Dravet Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of DS must fulfill all of the following criteria:\n\n 1. Participants with seizure onset age \\>1 and \\<20 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/leg 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/epileptic 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/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.\n* The participant is receiving exclusionary medications.\n* The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet 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/tachycardia), 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.'}, 'identificationModule': {'nctId': 'NCT06660394', 'briefTitle': 'A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Longboard Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LP352-302'}, 'secondaryIdInfos': [{'id': '2024-514937-39-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LP352', 'description': 'Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.', 'interventionNames': ['Drug: LP352']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for LP352', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LP352', 'type': 'DRUG', 'otherNames': ['Bexicaserin'], 'description': 'LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube', 'armGroupLabels': ['LP352']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Comparator'], 'description': 'Participants will be administered with matching placebo orally or through G-tube/ PEG tube', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202-3500', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Arkansas Children's Hospital - PIN", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095-8346', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304-1510', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Stanford Division of Child Neurology', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143-2350', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "UCSF Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045-7106', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Hospital Colorado.", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32561-4458', 'city': 'Gulf Breeze', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NW FL Clinical Research Group, LLC', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '33155-3009', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Nicklaus Children's Hospital - PIN", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806-5411', 'city': 'Orlando', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Research Institute of Orlando LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33609-4190', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pediatric Epilepsy and Neurology Specialists', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Rare Disease Research, LLC - Atlanta - RDR - PIN', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ann and Robert H Lurie Childrens Hospital of Chicago - PIN', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20817-1844', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid-Atlantic Epilepsy and Sleep Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - 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Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Strasbourg - Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31330', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '60528', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum der Johann-Wolfgang Goethe-Universitat', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '33617', 'city': 'Bielefeld', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Gesellschaft für Epilepsieforschung e.V.', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '24105', 'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein - Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '88214', 'city': 'Ravensburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Epilepsie-Zentrum Bodensee', 'geoPoint': {'lat': 47.78198, 'lon': 9.61062}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A Gemelli - Rome - PPDS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '37126', 'city': 'Verona', 'state': 'Veneto', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '16147', 'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '420-0953', 'city': 'Shizuoka', 'state': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '187-8502', 'city': 'Kodaira-Shi', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Center of Neurology and Psychiatry'}, {'zip': '534-0021', 'city': 'Osaka-Shi Miyakojima-Ku', 'state': 'Ôsaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Osaka City General Hospital'}, {'zip': 'LV-1004', 'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': "Children's Clinical University Hospital", 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '3000-602', 'city': 'Coimbra', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1649-035', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4050-651', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'ULS de Santo António, EPE - Centro Materno Infantil Norte', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '11000', 'city': 'Belgrade', 'state': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'University Clinical Center of Serbia - Dr Subotica 6 - PPDS', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Clinic for Neurology and Psychiatry for Children and Youth', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Mother and Child Health Care Institute of Serbia Dr Vukan Cupic', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'University Clinical Center Kragujevac', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '08950', 'city': 'Espluges de Llobregat', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu - PIN'}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Malaga - Hospital General', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28010', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Vithas Madrid La Milagrosa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Ruber Internacional (Grupo Quironsalud)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29016', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Vithas Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'Northamptonshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital - PPDS', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'CONTACT', 'email': 'LundbeckClinicalTrials@Lundbeck.com', 'phone': '+45 36301311'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Longboard Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}