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

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

Phase

3

Condition

Epilepsy

Dravet Syndrome

Neurologic Disorders

Treatment

LP352

Clinical Study ID

NCT06908226
LP352-303
2024-514974-39-00
  • Ages 2-66
  • All Genders

Study Summary

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8,and who, in the opinion of the investigator, may benefit from continued LP352administration.

  • Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS),or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).

  • Has at least one reliable and consistent parent, legal guardian, or caregiver duringthe study.

  • The participant or legal representative must be willing and able to provide writteninformed consent

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

Exclusion

Exclusion Criteria:

  • The participant is receiving exclusionary medications.

  • Current use of any cannabis product or cannabidiol that is not in oralsolution/capsule/tablet form, not obtained from a government-approved dispensary, orcontaining ≥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: 324
Treatment Group(s): 1
Primary Treatment: LP352
Phase: 3
Study Start date:
February 12, 2025
Estimated Completion Date:
December 31, 2027

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 - 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 - USA19

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • 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 32561
    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

    Site Not Available

  • Site Number - USA09

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Site Number - USA38

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Site Number - USA07

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • 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 07961
    United States

    Site Not Available

  • 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 - USA31

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Site Number - USA25

    Houston, Texas 77030
    United States

    Site Not Available

  • Site Number - USA03

    Tacoma, Washington 98405
    United States

    Site Not Available

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