A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Last updated: June 11, 2026
Sponsor: Longboard Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Holoprosencephaly

Autism

Dravet Syndrome

Treatment

LP352

Placebo

Clinical Study ID

NCT06719141
LP352-301
2024-516412-17-00
  • Ages 2-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) mustfulfill all of the following criteria:

  • Onset of seizures at ≤8 years old

  • History of tonic/tonic-atonic seizures plus at least 1 of the following seizuretype(s): atypical absence, atonic, myoclonic, focal impaired awareness,generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms

  • Presence of developmental plateauing or regression

  • History of electroencephalogram (EEG) showing generalized slow (<2.5 Hertz [Hz]) spike-and-wave complexes

  • Participants who are characterized as having DEE (Other) must fulfill all of thefollowing criteria:

  • Does not meet criteria for LGS

  • Onset of seizures at ≤5 years old

  • Presence of developmental plateauing or regression

  • History of multiple seizure types

  • History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)

  • The participant has a current occurrence of at least 1 of the following countablemotor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (includinghemiclonic), and focal to bilateral tonic-clonic.

  • The participant has demonstrated an average of at least 4 countable motor seizuresper month for each of the 3 months prior to Screening.

  • The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stabledose for at least 4 weeks prior to Screening.

  • The participant, parent, or caregiver is willing and able (in the judgment of theinvestigator) to comply with completion of the diaries throughout the study.

  • The participant must be willing and able to provide written informed consent; ininstances where the participant is unable to provide consent, an appropriate legalrepresentative.

Exclusion

Exclusion Criteria:

  • The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of theSodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.

  • The participant has been admitted to a medical facility for treatment of statusepilepticus requiring mechanical ventilation within 3 months prior to Screening.

  • The participant has a neurodegenerative disorder as indicated by magnetic resonanceimaging or genetic testing.

  • The participant has an acquired lesion/injury unrelated to the primary etiology thatcould contribute as a secondary cause of seizures.

  • The participant is receiving exclusionary medications.

  • The participant is currently using any cannabis product or cannabidiol that is notin oral solution/capsule/tablet form, not obtained from a government-approveddispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).

  • The participant has unstable, clinically significant neurologic (other than thedisease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg,pulmonary arterial hypertension, cardiac valvulopathy, orthostatichypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal,urologic, immunologic, hematopoietic, or endocrine disease or other abnormalitywhich may impact the ability of the participant to participate or potentiallyconfound the study results.

  • The participant is unable or unwilling to comply with any of the study requirementsor timelines.

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: LP352
Phase: 3
Study Start date:
November 11, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Site Number - AUS08

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Sydney Children's Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Sydney Children's Hospital

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Active - Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland 4006
    Australia

    Active - Recruiting

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Royal Children's Hospital Melbourne

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Active - Recruiting

  • UZ Antwerpen

    Edegem, Antwerp 2650
    Belgium

    Active - Recruiting

  • UZ Leuven - PPDS

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Instituto de Neurologia de Curitiba (INC)

    Curitiba, Paraná 81210-310
    Brazil

    Active - Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul 90035-001
    Brazil

    Active - Recruiting

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo 13083-888
    Brazil

    Active - Recruiting

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Active - Recruiting

  • Instituto de Psiquiatria HC FMUSP

    São Paulo, 05403-010
    Brazil

    Active - Recruiting

  • Children's and Women's Health Centre of British Columbia-4480 Oak St

    Vancouver, British Columbia V6H 3V4
    Canada

    Active - Recruiting

  • London Health Sciences Centre -800 Commissioners Rd E

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Hospital For Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Site Number - CAN 01

    Toronto, Ontario M5G 1E8
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • Peking University First Hospital - Daxing Campus

    Beijing, Beijing Municipality 102627
    China

    Active - Recruiting

  • Peking University First Hospital - Daxing Campus

    Beijing 1816670, Beijing Municipality 2038349 102627
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Active - Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • Wuhan Children's Hospital

    Wuhan, Hubei 430010
    China

    Active - Recruiting

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality 201102
    China

    Active - Recruiting

  • Beijing Children's Hospital, Capital Medical University - PIN

    Beijing, 100045
    China

    Active - Recruiting

  • Hôpital Roger Salengro

    Lille, Nord 59000
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron, 69500
    France

    Active - Recruiting

  • AP-HM- Hôpital de La Timone

    Marseille, 13386
    France

    Active - Recruiting

  • AP-HP - Hôpital universitaire Robert-Debré

    Paris, 75019
    France

    Active - Recruiting

  • Hôpital Necker - Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Site Number - FRA 05

    Paris, 75019
    France

    Site Not Available

  • AP-HP - Hôpital universitaire Robert-Debré

    Paris 2988507, 75019
    France

    Active - Recruiting

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35203
    France

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31330
    France

    Active - Recruiting

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse 60596
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia 53127
    Germany

    Active - Recruiting

  • Epilepsiezentrum Kleinwachau gemeinnützige Gmbh

    Radeberg, Saxony 01454
    Germany

    Completed

  • Gesellschaft für Epilepsieforschung e.V.

    Bielefeld, 33617
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214
    Germany

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, 00165
    Holy See

    Active - Recruiting

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Rome, Lazio 00168
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy 20133
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, Lombardy 27100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria A Meyer (Duplicate)

    Florence, Tuscany 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Florence, Tuscany 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto 37126
    Italy

    Active - Recruiting

  • Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)

    Genova, 16147
    Italy

    Active - Recruiting

  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genova, 16147
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, 00165
    Italy

    Active - Recruiting

  • Site Number - ITA 06

    Roma, 00165
    Italy

    Site Not Available

  • IUHW Narita Hospital

    Narita, Chiba 286-8520
    Japan

    Active - Recruiting

  • Fukuoka Children's Hospital

    Fukuoka, Fukuoka 813-0017
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaidô 060-8648
    Japan

    Active - Recruiting

  • National Hospital Organization Nishi-Niigata Chuo National Hospital

    Niigata, Niigata 950-2074
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, Okayama-ken 700-8558
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka-Shi Miyakojima-Ku, Osaka 534-0021
    Japan

    Active - Recruiting

  • Saitama Prefectural Children's Medical Center

    Saitama-shi, Saitama 330-8777
    Japan

    Active - Recruiting

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, Shizuoka 420-0953
    Japan

    Active - Recruiting

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo 187-8502
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Mibu-Machi, 321-0293
    Japan

    Active - Recruiting

  • Children's Clinical University Hospital

    Riga, Rīgas Apriņķis LV-1004
    Latvia

    Active - Recruiting

  • Site Number - MEX 01

    Mexico City, Cdmx 04530
    Mexico

    Site Not Available

  • Universitair Medisch Centrum Utrecht - PPDS

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

    Coimbra, 3000-602
    Portugal

    Active - Recruiting

  • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

    Lisbon, 1649-035
    Portugal

    Active - Recruiting

  • ULS de Santo António, EPE - Centro Materno Infantil Norte

    Porto, 4050-651
    Portugal

    Active - Recruiting

  • University Clinical Center of Serbia - Dr Subotica 6 - PPDS

    Belgrade, Belgrade 11000
    Serbia

    Active - Recruiting

  • University Clinical Center of Serbia - Dr Subotica 6 - PPDS

    Belgrade 792680, Belgrade 11000
    Serbia

    Active - Recruiting

  • Clinic for Neurology and Psychiatry for Children and Youth

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade, 190133
    Serbia

    Active - Recruiting

  • Site number - SRB 06

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade 792680, 190133
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Hospital Sant Joan de Deu - PIN

    Espluges de Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, Málaga 29010
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga 2514256, Málaga 29010
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Active - Recruiting

  • Site number - ESP 05

    Barcelona, 08035
    Spain

    Site Not Available

  • Site number - ESP 12

    Barcelona, 08950
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesus - PIN

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Ruber Internacional (Grupo Quironsalud)

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid, 28010
    Spain

    Active - Recruiting

  • Site number - ESP 03

    Madrid, 28034
    Spain

    Site Not Available

  • Site number - ESP 10

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Ruber Internacional (Grupo Quironsalud)

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid 3117735, 28010
    Spain

    Active - Recruiting

  • Hospital Vithas Malaga

    Málaga, 29016
    Spain

    Active - Recruiting

  • Site number - ESP 09

    Málaga, 29016
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, Northamptonshire NE1 4LP
    United Kingdom

    Active - Recruiting

  • Noah's Ark Children's Hospital for Wales - PIN

    Cardiff, South Glamorgan CF14 4XW
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital - PPDS

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Site number - GBR 03

    London, WC1N 3BH
    United Kingdom

    Site Not Available

  • University College London Hospitals (UCLH) - PPDS

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • University College London Hospitals (UCLH) - PPDS

    London 2643743, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Arkansas Children's Hospital - PIN

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles - PIN

    Los Angeles, California 90027-6062
    United States

    Active - Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • Site Number - USA26

    Los Angeles, California 90027
    United States

    Site Not Available

  • The Stanford Division of Child Neurology

    Palo Alto, California 94304-1510
    United States

    Active - Recruiting

  • UCSF Children's Hospital

    San Francisco, California 94143-2350
    United States

    Active - Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles 5368361, California 5332921 90095-8346
    United States

    Active - Recruiting

  • Children's Hospital Colorado.

    Aurora, Colorado 80045-7106
    United States

    Active - Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia 20010-2916
    United States

    Active - Recruiting

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561-4458
    United States

    Active - Recruiting

  • Site Number - USA02

    Gulf Breeze, Florida 32561
    United States

    Active - Recruiting

  • Nicklaus Children's Hospital - PIN

    Miami, Florida 33155-3009
    United States

    Active - Recruiting

  • University of Miami - 1120 NW 14th St

    Miami, Florida 33136-2107
    United States

    Active - Recruiting

  • Research Institute of Orlando LLC

    Orlando, Florida 32806-5411
    United States

    Completed

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida 33609-4190
    United States

    Active - Recruiting

  • Site Number - USA11

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • University of South Florida - 2 Tampa General Circle

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Nicklaus Children's Hospital - PIN

    Miami 4164138, Florida 4155751 33155-3009
    United States

    Active - Recruiting

  • Pediatric Epilepsy and Neurology Specialists

    Tampa 4174757, Florida 4155751 33609-4190
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Rare Disease Research, LLC - Atlanta - RDR - PIN

    Atlanta, Georgia 30329
    United States

    Completed

  • Rare Disease Research, LLC - Atlanta - RDR - PIN

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Completed

  • Consultants In Epilepsy and Neurology PLLC

    Boise, Idaho 83702-5029
    United States

    Active - Recruiting

  • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611-5975
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics - (CRS)

    Iowa City, Iowa 52242-1009
    United States

    Active - Recruiting

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland 20817-1844
    United States

    Active - Recruiting

  • Massachusetts General Hospital - 175 Cambridge St

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Site Number - USA 40

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Site Number - USA30

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mayo Clinic - PIN

    Rochester, Minnesota 55905-0001
    United States

    Active - Recruiting

  • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

    Livingston, New Jersey 07039-5817
    United States

    Active - Recruiting

  • Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Site Number - USA36

    Morristown, New Jersey 07961
    United States

    Site Not Available

  • NYU Comprehensive Epilepsy Center - BRANY - PPDS

    New York, New York 10016-4852
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239-3011
    United States

    Active - Recruiting

  • Le Bonheur Childrens Outpatient Center - PIN

    Memphis, Tennessee 38103-2816
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital

    Memphis 4641239, Tennessee 4662168 38103-2816
    United States

    Active - Recruiting

  • Le Bonheur Childrens Outpatient Center - PIN

    Memphis 4641239, Tennessee 4662168 38103-2816
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin - 6811 Austin Center Blvd

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Site Number - USA 41

    Austin, Texas 78757
    United States

    Site Not Available

  • Cook Children's Jane and John Justin Neurosciences Center - PIN

    Fort Worth, Texas 76104-2710
    United States

    Active - Recruiting

  • The University of Texas Medical School at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin

    Austin 4671654, Texas 4736286 78757
    United States

    Active - Recruiting

  • Cook Children's Medical Center - Jane and John Justin Neurosciences Center

    Fort Worth 4691930, Texas 4736286 76104-2710
    United States

    Active - Recruiting

  • Multicare Health System - Mary Bridge Pediatrics

    Tacoma, Washington 98405-4048
    United States

    Active - Recruiting

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