A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

Last updated: April 9, 2025
Sponsor: Longboard Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Seizure Disorders (Pediatric)

Dravet Syndrome

Unverricht-lundborg Syndrome

Treatment

LP352

Placebo

Clinical Study ID

NCT06660394
LP352-302
2024-514937-39-00
  • Ages 2-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of DS must fulfill all of the following criteria:
  1. Participants with seizure onset age >1 and <20 months

  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

  • 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 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.

Exclusion

Exclusion Criteria:

  • The participant has a history of infantile/epileptic spasms.

  • 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 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 unwilling to comply with any of the study requirements ortimelines.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: LP352
Phase: 3
Study Start date:
October 02, 2024
Estimated Completion Date:
October 31, 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 - AUS09

    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 - AUS06

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Site Number - BEL01

    Edegem, 2650
    Belgium

    Site Not Available

  • Site Number - BEL02

    Leuven, 3000
    Belgium

    Site Not Available

  • Site Number - BRA02

    Ribeirão Preto, SP 14015-010
    Brazil

    Site Not Available

  • Site Number - BRA05

    São José Do Rio Preto, SP 15090-000
    Brazil

    Site Not Available

  • Site Number - BRA03

    São Paulo, SP 05403-903
    Brazil

    Site Not Available

  • Site Number - BRA01

    Curitiba, 81210-310
    Brazil

    Site Not Available

  • Site Number - CAN04

    Vancouver, British Columbia V5Z 4H4
    Canada

    Site Not Available

  • Site Number - CAN01

    Toronto, Ontario M5G 1E8
    Canada

    Site Not Available

  • Site Number - CAN03

    Toronto, Ontario M5T 0S8
    Canada

    Site Not Available

  • Site Number - CHN01

    Beijing, 100034
    China

    Site Not Available

  • Site Number - FRA08

    Bron, 69500
    France

    Site Not Available

  • Site Number - FRA04

    Lille, 59037
    France

    Site Not Available

  • Site Number - FRA06

    Marseille, 13005
    France

    Site Not Available

  • Site Number - FRA05

    Paris, 75019
    France

    Site Not Available

  • Site Number - FRA09

    Paris, 75015
    France

    Site Not Available

  • Site Number - FRA01

    Rennes, 35000
    France

    Site Not Available

  • Site Number - FRA07

    Strasbourg, 67200
    France

    Site Not Available

  • Site Number - FRA03

    Toulouse, 31300
    France

    Site Not Available

  • Site Number - DEU02

    Bielefeld, 33617
    Germany

    Site Not Available

  • Site Number - DEU07

    Bonn, 53127
    Germany

    Site Not Available

  • Site Number - DEU01

    Frankfurt, 60596
    Germany

    Site Not Available

  • Site Number - DEU04

    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

  • Site Number - DEU03

    Kiel, 24105
    Germany

    Site Not Available

  • Site Number - DEU06

    Radeberg, 01454
    Germany

    Site Not Available

  • Site Number - DEU05

    Ravensburg, 88214
    Germany

    Site Not Available

  • Site Number - ITA03

    Genova, 16147
    Italy

    Site Not Available

  • Site Number - ITA02

    Pavia, 27100
    Italy

    Site Not Available

  • Site Number - ITA01

    Roma, 00168
    Italy

    Site Not Available

  • Site Number - ITA06

    Roma, 00165
    Italy

    Site Not Available

  • Site Number - ITA04

    Toscana, 50139
    Italy

    Site Not Available

  • Site Number - ITA08

    Verona, 37126
    Italy

    Site Not Available

  • Site Number - LAV01

    Riga, 1004
    Latvia

    Site Not Available

  • Site Number - MEX01

    Mexico City, Cdmx 04530
    Mexico

    Site Not Available

  • Site Number - MEX02

    Mexico City, Cdmx 06720
    Mexico

    Site Not Available

  • Site Number - NLD02

    Zwolle, BV 8025
    Netherlands

    Site Not Available

  • Site Number - PRT02

    Coimbra, 3004-561
    Portugal

    Site Not Available

  • Site Number - PRT03

    Lisbon, 1649-028
    Portugal

    Site Not Available

  • Site Number - PRT05

    Porto Covo, 4050-651
    Portugal

    Site Not Available

  • Site Number - SRB02

    Belgrade, 11070
    Serbia

    Site Not Available

  • Site Number SRB 06

    Belgrade, 11000
    Serbia

    Site Not Available

  • Site Number - SRB03

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Site Number - ESP02

    Barcelona, 8025
    Spain

    Site Not Available

  • Site Number - ESP05

    Barcelona, 08035
    Spain

    Site Not Available

  • Site Number - ESP12

    Barcelona, 08950
    Spain

    Site Not Available

  • Site Number - ESP011

    Madrid, 28010
    Spain

    Site Not Available

  • Site Number - ESP03

    Madrid, 28034
    Spain

    Site Not Available

  • Site Number - ESP04

    Málaga, 29010
    Spain

    Site Not Available

  • Site Number - ESP09

    Málaga, 29016
    Spain

    Site Not Available

  • Site Number - ESP06

    Pamplona, 31009
    Spain

    Site Not Available

  • Site Number - ESP08

    Valencia, 46026
    Spain

    Site Not Available

  • Site Number - GBR04

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Site Number - GBR03

    London, WC1N 3BH
    United Kingdom

    Site Not Available

  • Site Number - GBRXX

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Site Number - GBR05

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Site Number - GBR02

    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

    Site Not Available

  • 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 - 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 - USA07

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • 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

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  • 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 - 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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