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

Last updated: January 2, 2026
Sponsor: Longboard Pharmaceuticals
Overall Status: Active - Enrolling

Phase

3

Condition

Tic Disorders

Neuronal Ceroid Lipofuscinoses (Ncl)

Autism

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).

  • Participant has a body weight of ≥10 kg.

  • G-tubes/PEG tubes (if applicable) should be in stable and good working condition.Nasogastric tubes are not allowed except for short-term management.

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

  • The participant must be willing and able to provide written informed consent; ininstances where the participant is unable to provide consent, an appropriate LARmust provide informed consent and the participant will need to assent (as per localregulations) before participation in the study. If the participant cannot provideconsent or assent (ie, due to developmental status), the investigator shoulddocument why it was not obtained.

  • The participant and/or authorized representative is willing to provide writtenconsent or assent to allow the investigator and the investigator's staff to consultwith the participant's medical caregivers and the medical monitor during Screeningand during participation in the study.

  • All participants of childbearing potential must have a negative urine or serumpregnancy (human chorionic gonadotropin) test at Visit 8 from Study LP352-301 orLP352-302 and agrees to routinely use an acceptable effective method ofcontraception from the time of signing informed consent up to 48 hours after thelast dose of study drug.

  • Participant and/or participant's caregiver(s) agree to not post any participant'spersonal medical data related to the study or information related to the study onany website or social media site until the study has been completed.

  • 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.

  • Considered at risk of suicidal behavior based on the C-SSRS at Visit 8 of LP352-301or LP352-302. If the participant is unable to complete the C-SSRS due todevelopmental status, the participant's LAR may not complete the C-SSRS. In thesecases, the investigator may use clinical judgment to assess both the participant'sstatus regarding suicidality and the ability to complete the scale, both of whichmust then be documented in the source document.

  • Has a PHQ-9 score of >9 or a positive response to Question 9 at Visit 8 of LP352-301or LP352-302. If the participant is unable to complete the PHQ-9, the participant'sLAR may not complete the PHQ-9. In these cases, the investigator may use clinicaljudgment to assess both the participant's status and ability to complete the scale,both of which must then be documented in the source document.

  • Ongoing AE from LP352-301 or LP352-302 of severe depression, anorexia nervosa, orbulimia per the Diagnostic and Statistical Manual of Mental Disorders, FifthEdition.

  • Has an abnormal and clinically significant 12-lead ECG at Visit 8 in LP352-301 orLP352-302 in the opinion of the investigator, for example, second- or third-degreeheart block or a QTc of >450 msec for adult males, >470 msec for adult females, or >440 msec for pediatric participants.

  • Ongoing AE in LP352-301 or LP352-302 of alcohol, opioid, or other drug use disorder,as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

  • 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% THC. Cannabis product or cannabidiol should be used primarily totreat seizures and dose should not be adjusted for the duration of the study.Cannabis product or cannabidiol will count as a concurrent ASM.

  • Has a positive result on the urine drug screen at Visit 8 of LP352-301 or LP352-302,except for positive results related to prescribed controlled medications (eg,benzodiazepine) or Epidiolex®/government-approved cannabis product/cannabidiol usedto treat seizures (eg, tetrahydrocannabinol).

  • Unstable, clinically significant neurologic (other than the disease being studied,eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterialhypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary,hepatic (severe hepatic impairment), renal (severe renal impairment), metabolic,gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease orother abnormality at Visit 8 of LP352-301 or LP352-302 which may impact the abilityof the participant to participate or potentially confound the study results.

  • Is pregnant, breast-feeding, or intending to become pregnant during or within 48hours after the last dose of study drug; or intending to donate ova during such timeperiod.

  • Has a known hypersensitivity to any component of LP352 formulation or any history ofserious drug-induced hypersensitivity, eg, toxic epidermal necrolysis or DrugReaction with Eosinophilia and Systemic Symptoms.

  • Unwilling to abstain from donation of blood during and within 2 weeks after thestudy.

  • Is unable or unwilling to comply with any of the study requirements or 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 17, 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

  • Austin Hospital

    Heidelberg 2163654, Victoria 2145234 3084
    Australia

    Site Not Available

  • AP-HP - Hôpital universitaire Robert-Debré

    Paris 2988507, 75019
    France

    Site Not Available

  • Children's Clinical University Hospital

    Riga 456172, LV-1004
    Latvia

    Site Not Available

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

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Hospital de La Santa Creu i Sant Pau

    Barcelona 3128760, 8041
    Spain

    Site Not Available

  • Hospital Ruber Internacional (Grupo Quironsalud)

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid 3117735, 28010
    Spain

    Site Not Available

  • Site Number - USA19

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's Hospital - PIN

    Little Rock 4119403, Arkansas 4099753 72202-3500
    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

  • David Geffen School of Medicine at UCLA

    Los Angeles 5368361, California 5332921 90095
    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

    Site Not Available

  • Site Number - USA37

    Miami, Florida 33155
    United States

    Site Not Available

  • Site Number - USA05

    Orlando, Florida 32806
    United States

    Site Not Available

  • Site Number - USA11

    Tampa, Florida 33609
    United States

    Site Not Available

  • NW FL Clinical Research Group, LLC

    Gulf Breeze 4157634, Florida 4155751 32561-4458
    United States

    Site Not Available

  • Research Institute of Orlando LLC

    Orlando 4167147, Florida 4155751 32806-5411
    United States

    Site Not Available

  • Pediatric Epilepsy and Neurology Specialists

    Tampa 4174757, Florida 4155751 33609-4181
    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

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda 4348599, Maryland 4361885 20817-1809
    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

    Site Not Available

  • Site Number - USA36

    Morristown, New Jersey 07961
    United States

    Site Not Available

  • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

    Livingston 5100572, New Jersey 5101760 07039-5817
    United States

    Site Not Available

  • Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

    Morristown 5101427, New Jersey 5101760 07960
    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

  • The University of Texas Medical School at Houston

    Houston 4699066, Texas 4736286 77030-3000
    United States

    Site Not Available

  • Site Number - USA03

    Tacoma, Washington 98405
    United States

    Site Not Available

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