Actively Recruiting

Phase 3
Age: 2Years - 65Years
All Genders
NCT06719141

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

Led by Longboard Pharmaceuticals · Updated on 2026-04-15

320

Participants Needed

109

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with Lennox-Gastaut Syndrome (LGS) must have seizure onset at 8 years old or younger
  • LGS participants must have tonic/tonic-atonic seizures plus at least one other seizure type such as atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms
  • Presence of developmental plateauing or regression is required for LGS participants
  • LGS participants must have EEG history showing generalized slow spike-and-wave complexes
  • Participants with other types of DEE must not meet LGS criteria
  • Other DEE participants must have seizure onset at 5 years old or younger
  • Other DEE participants must have developmental plateauing or regression
  • Other DEE participants must have history of multiple seizure types
  • Other DEE participants must have EEG showing diffuse or multifocal slowing
  • Participants must currently have at least one countable motor seizure type such as generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with trunk/leg involvement, focal motor, or focal to bilateral tonic-clonic
  • Participants must average at least 4 countable motor seizures per month for 3 months prior to screening
  • Participants must be taking 1 to 4 antiseizure medications at stable doses for at least 4 weeks prior to screening
  • Participants or their caregivers must be willing and able to complete seizure diaries throughout the study
  • Participants or their legal representatives must be willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Participants diagnosed with Dravet Syndrome or having SCN1A gene mutations consistent with Dravet Syndrome are excluded
  • Participants admitted for status epilepticus requiring mechanical ventilation within 3 months prior to screening are excluded
  • Participants with neurodegenerative disorders based on MRI or genetic testing are excluded
  • Participants with acquired brain lesions or injuries unrelated to the primary cause of seizures are excluded
  • Participants receiving exclusionary medications are excluded
  • Participants currently using cannabis or cannabidiol products not in approved oral forms or with high THC content (>50%) are excluded
  • Participants with unstable or significant neurologic, psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine diseases that may affect participation are excluded
  • Participants unable or unwilling to comply with study requirements or timelines are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 109 locations

1

Arkansas Children's Hospital - PIN

Little Rock, Arkansas, United States, 72202

Actively Recruiting

2

Children's Hospital Los Angeles - PIN

Los Angeles, California, United States, 90027-6062

Actively Recruiting

3

David Geffen School of Medicine at UCLA

Los Angeles, California, United States, 90095-3075

Actively Recruiting

4

The Stanford Division of Child Neurology

Palo Alto, California, United States, 94304-1510

Actively Recruiting

5

UCSF Children's Hospital

San Francisco, California, United States, 94143-2350

Actively Recruiting

6

Children's Hospital Colorado.

Aurora, Colorado, United States, 80045-7106

Actively Recruiting

7

Children's National Medical Center

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

Actively Recruiting

8

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States, 32561-4458

Actively Recruiting

9

University of Miami - 1120 NW 14th St

Miami, Florida, United States, 33136-2107

Actively Recruiting

10

Nicklaus Children's Hospital - PIN

Miami, Florida, United States, 33155-3009

Actively Recruiting

11

Research Institute of Orlando LLC

Orlando, Florida, United States, 32806-5411

Completed

12

University of South Florida - 2 Tampa General Circle

Tampa, Florida, United States, 33606

Actively Recruiting

13

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States, 33609-4190

Actively Recruiting

14

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

Atlanta, Georgia, United States, 30329

Actively Recruiting

15

Rare Disease Research, LLC - Atlanta - RDR - PIN

Atlanta, Georgia, United States, 30329

Completed

16

Consultants In Epilepsy and Neurology PLLC

Boise, Idaho, United States, 83702-5029

Actively Recruiting

17

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Chicago, Illinois, United States, 60611

Actively Recruiting

18

University of Iowa Hospitals & Clinics - (CRS)

Iowa City, Iowa, United States, 52242-1009

Actively Recruiting

19

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States, 20817-1844

Actively Recruiting

20

Massachusetts General Hospital - 175 Cambridge St

Boston, Massachusetts, United States, 02114

Actively Recruiting

21

Mayo Clinic - PIN

Rochester, Minnesota, United States, 55905-0001

Actively Recruiting

22

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, United States, 07039-5817

Actively Recruiting

23

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey, United States, 07960

Actively Recruiting

24

NYU Comprehensive Epilepsy Center - BRANY - PPDS

New York, New York, United States, 10016-4852

Actively Recruiting

25

Oregon Health and Science University

Portland, Oregon, United States, 97239-3011

Actively Recruiting

26

Le Bonheur Childrens Outpatient Center - PIN

Memphis, Tennessee, United States, 38103-2816

Actively Recruiting

27

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas, United States, 78757

Actively Recruiting

28

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

Fort Worth, Texas, United States, 76104-2710

Actively Recruiting

29

The University of Texas Medical School at Houston

Houston, Texas, United States, 77030

Actively Recruiting

30

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington, United States, 98405-4048

Actively Recruiting

31

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

32

Sydney Children's Hospital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

33

Children's Hospital at Westmead

Westmead, New South Wales, Australia, 2145

Actively Recruiting

34

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia, 4006

Actively Recruiting

35

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

36

Austin Hospital

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

37

Royal Children's Hospital Melbourne

Parkville, Victoria, Australia, 3052

Actively Recruiting

38

The Alfred Hospital

Melbourne, Australia, 3004

Actively Recruiting

39

UZ Antwerpen

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

40

UZ Leuven - PPDS

Leuven, Belgium, 3000

Actively Recruiting

41

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, Brazil, 81210-310

Actively Recruiting

42

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

Ribeirão Preto, São Paulo, Brazil, 14051-140

Actively Recruiting

43

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

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

Actively Recruiting

44

Instituto de Psiquiatria HC FMUSP

São Paulo, Brazil, 05403-010

Actively Recruiting

45

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

Vancouver, British Columbia, Canada, V6H 3V4

Actively Recruiting

46

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada, N6A 5W9

Actively Recruiting

47

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality, China, 102627

Actively Recruiting

48

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

49

Shenzhen Children's Hospital

Shenzhen, Guangdong, China, 518000

Actively Recruiting

50

Wuhan Children's Hospital

Wuhan, Hubei, China, 430010

Actively Recruiting

51

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

52

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, China, 100045

Actively Recruiting

53

Hôpital Roger Salengro

Lille, Nord, France, 59000

Actively Recruiting

54

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, France, 69500

Actively Recruiting

55

AP-HM- Hôpital de La Timone

Marseille, France, 13386

Actively Recruiting

56

Hôpital Necker - Enfants Malades

Paris, France, 75015

Actively Recruiting

57

AP-HP - Hôpital universitaire Robert-Debré

Paris, France, 75019

Actively Recruiting

58

CHU de Rennes - Hôpital Pontchaillou

Rennes, France, 35203

Actively Recruiting

59

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France, 67098

Actively Recruiting

60

Centre Hospitalier Universitaire de Toulouse

Toulouse, France, 31330

Actively Recruiting

61

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, Germany, 60596

Actively Recruiting

62

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

63

Epilepsiezentrum Kleinwachau gemeinnützige Gmbh

Radeberg, Saxony, Germany, 01454

Actively Recruiting

64

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, Germany, 33617

Actively Recruiting

65

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany, 24105

Actively Recruiting

66

Epilepsie-Zentrum Bodensee

Ravensburg, Germany, 88214

Actively Recruiting

67

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Roma, Holy See, 00165

Actively Recruiting

68

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy, 00168

Actively Recruiting

69

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Actively Recruiting

70

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy, 27100

Actively Recruiting

71

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, Italy, 50139

Actively Recruiting

72

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, Italy, 37126

Actively Recruiting

73

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genova, Italy, 16147

Actively Recruiting

74

IUHW Narita Hospital

Narita, Chiba, Japan, 286-8520

Actively Recruiting

75

Hokkaido University Hospital

Sapporo, Hokkaidô, Japan, 060-8648

Actively Recruiting

76

Fukuoka Children's Hospital

Fukuoka, Hukuoka, Japan, 813-0017

Actively Recruiting

77

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, Japan, 950-2074

Actively Recruiting

78

Okayama University Hospital

Okayama, Okayama-ken, Japan, 700-8558

Actively Recruiting

79

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan, 330-8777

Actively Recruiting

80

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan, 420-0953

Actively Recruiting

81

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, Japan, 187-8502

Actively Recruiting

82

Dokkyo Medical University Hospital

Mibu-Machi, Japan, 321-0293

Actively Recruiting

83

Osaka City General Hospital

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

Actively Recruiting

84

Children's Clinical University Hospital

Riga, Latvia, LV-1004

Actively Recruiting

85

Universitair Medisch Centrum Utrecht - PPDS

Utrecht, Netherlands, 3584 CX

Actively Recruiting

86

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal, 3000-602

Actively Recruiting

87

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

Lisbon, Portugal, 1649-035

Actively Recruiting

88

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto, Portugal, 4050-651

Actively Recruiting

89

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade, Serbia, 11000

Actively Recruiting

90

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, Serbia, 11000

Actively Recruiting

91

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, Serbia, 190133

Actively Recruiting

92

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

93

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona, Spain, 08950

Actively Recruiting

94

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, Spain, 29010

Actively Recruiting

95

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

96

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 08035

Actively Recruiting

97

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain, 8041

Actively Recruiting

98

Hospital Infantil Universitario Niño Jesus - PIN

Madrid, Spain, 28009

Actively Recruiting

99

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain, 28010

Actively Recruiting

100

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain, 28034

Actively Recruiting

101

Hospital Vithas Malaga

Málaga, Spain, 29016

Actively Recruiting

102

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Actively Recruiting

103

Queen Elizabeth University Hospital - PPDS

Glasgow, Glasgow City, United Kingdom, G51 4TF

Actively Recruiting

104

Royal Victoria Infirmary

Newcastle upon Tyne, Northamptonshire, United Kingdom, NE1 4LP

Actively Recruiting

105

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

Cardiff, South Glamorgan, United Kingdom, CF14 4XW

Actively Recruiting

106

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2GW

Actively Recruiting

107

University College London Hospitals (UCLH) - PPDS

London, United Kingdom, NW1 2PG

Actively Recruiting

108

Great Ormond Street Hospital - PPDS

London, United Kingdom, WC1N 3JH

Actively Recruiting

109

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

E

Email contact via H. Lundbeck A/S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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