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

Last updated: May 8, 2025
Sponsor: Longboard Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Dravet Syndrome

Epilepsy

Neurologic Disorders

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 has used of any cannabis product or cannabidiol that is not in oralsolution/capsule/tablet form, not obtained from a government-approved dispensary, orcontains ≥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

  • Site Number - AUS07

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Site Number - AUS08

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Site Number - AUS 09

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Site Number - AUS04

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Site Number - AUS05

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Site Number - AUS02

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Site Number - AUS03

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Site Number - AUS 06

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Site Number - BEL 01

    Edegem, 2650
    Belgium

    Site Not Available

  • Site Number - BEL 02

    Leuven, 3000
    Belgium

    Site Not Available

  • Site Number - BRA 01

    Curitiba, PR 81210-310
    Brazil

    Site Not Available

  • Site Number - BRA 02

    Ribeirão Preto, SP 14015-010
    Brazil

    Site Not Available

  • Site Number - BRA 05

    São José Do Rio Preto, SP 15090-000
    Brazil

    Site Not Available

  • Site Number - BRA 03

    São Paulo, SP 05403-903
    Brazil

    Site Not Available

  • Site Number - CAN 04

    Vancouver, British Columbia V5Z 4H4
    Canada

    Site Not Available

  • Site Number - CAN 01

    Toronto, Ontario M5G 1E8
    Canada

    Site Not Available

  • Site Number - CAN 03

    Toronto, Ontario M5T 0S8
    Canada

    Site Not Available

  • Site Number - CHN 01

    Beijing, 100034
    China

    Site Not Available

  • Site Number - FRA 08

    Bron, 69500
    France

    Site Not Available

  • Site Number - FRA 04

    Lille, 59037
    France

    Site Not Available

  • Site Number - FRA 06

    Marseille, 13005
    France

    Site Not Available

  • Site Number - FRA 05

    Paris, 75019
    France

    Site Not Available

  • Site Number - FRA 09

    Paris, 75015
    France

    Site Not Available

  • Site Number - FRA 01

    Rennes, 35000
    France

    Site Not Available

  • Site Number - FRA 07

    Strasbourg, 67200
    France

    Site Not Available

  • Site Number - FRA 03

    Toulouse, 31300
    France

    Site Not Available

  • Site Number - DEU 02

    Bielefeld, 33617
    Germany

    Site Not Available

  • Site Number - DEU 07

    Bonn, 53127
    Germany

    Site Not Available

  • Site Number - DEU 01

    Frankfurt, 60596
    Germany

    Site Not Available

  • Site Number - DEU 04

    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

  • Site Number - DEU 03

    Kiel, 24105
    Germany

    Site Not Available

  • Site Number - DEU 06

    Radeberg, 01454
    Germany

    Site Not Available

  • Site Number - DEU 05

    Ravensburg, 88214
    Germany

    Site Not Available

  • Site Number - ITA 03

    Genova, 16147
    Italy

    Site Not Available

  • Site Number - ITA 07

    Milan, 20133
    Italy

    Site Not Available

  • Site Number - ITA 02

    Pavia, 27100
    Italy

    Site Not Available

  • Site Number - ITA 01

    Roma, 00168
    Italy

    Site Not Available

  • Site Number - ITA 06

    Roma, 00165
    Italy

    Site Not Available

  • Site Number - ITA 04

    Toscana, 50139
    Italy

    Site Not Available

  • Site Number - ITA 08

    Verona, 37126
    Italy

    Site Not Available

  • Site Number - LVA 01

    Riga, 1004
    Latvia

    Site Not Available

  • Site Number - MEX 01

    Mexico City, Cdmx 04530
    Mexico

    Site Not Available

  • Site Number - MEX 02

    Mexico City, 06720
    Mexico

    Site Not Available

  • Site Number - NLD 02

    Zwolle, BV 8025
    Netherlands

    Site Not Available

  • Site Number - NLD 03

    Utrecht, CX 3584
    Netherlands

    Site Not Available

  • Site Number - PRT 02

    Coimbra, 3004-561
    Portugal

    Site Not Available

  • Site Number - PRT 03

    Lisbon, 1649-028
    Portugal

    Site Not Available

  • Site Number - PRT 05

    Porto Covo, 4050-651
    Portugal

    Site Not Available

  • Site Number - SRB 02

    Belgrade, 11070
    Serbia

    Site Not Available

  • Site number - SRB 06

    Belgrade, 11000
    Serbia

    Site Not Available

  • Site Number - SRB 03

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Site number - ESP 02

    Barcelona, 8025
    Spain

    Site Not Available

  • Site number - ESP 05

    Barcelona, 08035
    Spain

    Site Not Available

  • Site number - ESP 12

    Barcelona, 08950
    Spain

    Site Not Available

  • Site number - ESP 03

    Madrid, 28034
    Spain

    Site Not Available

  • Site number - ESP 10

    Madrid, 28009
    Spain

    Site Not Available

  • Site number - ESP 11

    Madrid, 28010
    Spain

    Site Not Available

  • Site number - ESP 04

    Málaga, 29010
    Spain

    Site Not Available

  • Site number - ESP 09

    Málaga, 29016
    Spain

    Site Not Available

  • Site number - ESP 06

    Pamplona, 31009
    Spain

    Site Not Available

  • Site number - ESP 08

    Valencia, 46026
    Spain

    Site Not Available

  • Site number - GBR 01

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Site number - GBR 04

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Site number - GBR 03

    London, WC1N 3BH
    United Kingdom

    Site Not Available

  • Site number - GBRXX

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Site number - GBR 05

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Site number - GBR 02

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Site Number - USA19

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Site Number - USA29

    La Jolla, California 92037
    United States

    Site Not Available

  • Site Number - USA18

    Los Angeles, California 90095
    United States

    Site Not Available

  • Site Number - USA26

    Los Angeles, California 90027
    United States

    Site Not Available

  • Site Number - USA24

    Palo Alto, California 94304
    United States

    Site Not Available

  • Site Number - USA28

    San Francisco, California 94904
    United States

    Site Not Available

  • Site Number - USA17

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Site Number - USA02

    Gulf Breeze, Florida 32806
    United States

    Active - Recruiting

  • Site Number - USA37

    Miami, Florida 33155
    United States

    Site Not Available

  • Site Number - USA05

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Site Number - USA 08

    Tampa, Florida 33606
    United States

    Site Not Available

  • Site Number - USA11

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Site Number - USA09

    Atlanta, Georgia 30329
    United States

    Terminated

  • Site Number - USA38

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Site Number - USA 13

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Site Number - USA07

    Bethesda, Maryland 20817
    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

  • Site Number - USA40

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Site Number - USA15

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Site Number - USA10

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Site Number - USA36

    Morristown, New Jersey 07601
    United States

    Active - Recruiting

  • Site Number - USA32

    New York, New York 10016
    United States

    Site Not Available

  • Site Number - USA14

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Site Number - USA39

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Site Number - USA35

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Site Number - USA33

    Portland, Oregon 97239
    United States

    Site Not Available

  • Site Number - USA22

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Site Number - USA34

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Site Number - USA 41

    Austin, Texas 78757
    United States

    Site Not Available

  • Site Number - USA41

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Site Number - USA31

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Site Number - USA25

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Site Number - USA03

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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