Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT05626634
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}, {'id': 'D065768', 'term': 'Lennox Gastaut Syndrome'}, {'id': 'C564064', 'term': 'CDKL5 deficiency disorder'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D014402', 'term': 'Tuberous Sclerosis'}], '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': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D065703', 'term': 'Malformations of Cortical Development, Group I'}, {'id': 'D054220', 'term': 'Malformations of Cortical Development'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-12-02', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'dispFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent Adverse Events', 'timeFrame': 'Baseline up to Week 52', 'description': 'Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS) Response', 'timeFrame': 'Baseline up to Week 52', 'description': 'Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior'}, {'measure': 'Patient Health Questionnaire-9 Total Score and Question 9 Score', 'timeFrame': 'Baseline up to Week 52', 'description': 'Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period', 'timeFrame': 'Baseline to Week 50', 'description': 'Baseline Used for Seizure Frequency = Baseline from Study LP352-201 and Baseline from Study LP352-202'}, {'measure': 'Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'Percent Reduction in Individual Seizure Type During the Treatment Period', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'Proportion of Subjects Requiring Rescue Medication During the Treatment Period', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'Percentage Change from Baseline in Non-motor and Difficult to Count Seizures', 'timeFrame': 'Baseline to Week 50'}, {'measure': 'LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period', 'timeFrame': 'Baseline to Week 50'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CDKL5 deficiency disorder', 'developmental and epileptic encephalopathy', 'Dravet Syndrome', 'epilepsy', 'Lennox-Gastaut Syndrome', 'treatment resistant epilepsy', 'tuberous sclerosis complex'], 'conditions': ['Developmental and Epileptic Encephalopathy', 'Dravet Syndrome', 'Lennox-Gastaut Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.', 'detailedDescription': 'This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201.\n\nThe study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201\n2. Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy\n3. The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed\n\nExclusion Criteria:\n\n1. Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug\n2. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure\n3. Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject\n4. Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior\n5. Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss\n6. Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol'}, 'identificationModule': {'nctId': 'NCT05626634', 'briefTitle': 'Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Longboard Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks', 'orgStudyIdInfo': {'id': 'LP352-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LP352, bexicaserin', 'description': 'Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 48-week maintenance period and a 15-day taper/down titration period.', 'interventionNames': ['Drug: LP352, bexicaserin']}], 'interventions': [{'name': 'LP352, bexicaserin', 'type': 'DRUG', 'description': 'LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube', 'armGroupLabels': ['LP352, bexicaserin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos National Rehabilitation Center (RLANRC)', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'country': 'United States', 'facility': 'Northwest Florida Clinical Research Group', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Institute of Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Neuroscience', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Epilepsy and Sleep Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10532', 'city': 'Hawthorne', 'state': 'New York', 'country': 'United States', 'facility': "Boston Children's Health Physicians LLP", 'geoPoint': {'lat': 41.10732, 'lon': -73.79597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Northeast Regional Epilepsy Group', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '98277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Neurological Specialties-East', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Child Neurology Consultants of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Epilepsy Care Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Valley Medical Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Dennis J Dlugos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Longboard Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}