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ENROLLING BY INVITATION

NCT06908226

PHASE3

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

Sponsor: Longboard Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

Key Details

Gender

All

Age Range

2 Years - 66 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2025-02-12

Completion Date

2027-12-17

Last Updated

2026-08-12

Healthy Volunteers

Conditions

Developmental and Epileptic Encephalopathy

Interventions

DRUG

LP352

LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube.

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 LP352 administration. * 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 during the study. * The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate LAR must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study. If the participant cannot provide consent or assent (ie, due to developmental status), the investigator should document why it was not obtained. * The participant and/or authorized representative is willing to provide written consent or assent to allow the investigator and the investigator's staff to consult with the participant's medical caregivers and the medical monitor during Screening and during participation in the study. * All participants of childbearing potential must have a negative urine or serum pregnancy (human chorionic gonadotropin) test at Visit 8 from Study LP352-301 or LP352-302 and agrees to routinely use an acceptable effective method of contraception from the time of signing informed consent up to 48 hours after the last dose of study drug. * Participant and/or participant's caregiver(s) agree to not post any participant's personal medical data related to the study or information related to the study on any website or social media site until the study has been completed. * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study. Exclusion Criteria: * The participant is receiving exclusionary medications. * Considered at risk of suicidal behavior based on the C-SSRS at Visit 8 of LP352-301 or LP352-302. If the participant is unable to complete the C-SSRS due to developmental status, the participant's LAR may not complete the C-SSRS. In these cases, the investigator may use clinical judgment to assess both the participant's status regarding suicidality and the ability to complete the scale, both of which must 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 LP352-301 or LP352-302. If the participant is unable to complete the PHQ-9, the participant's LAR may not complete the PHQ-9. In these cases, the investigator may use clinical judgment 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, or bulimia per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. * Has an abnormal and clinically significant 12-lead ECG at Visit 8 in LP352-301 or LP352-302 in the opinion of the investigator, for example, second- or third-degree heart 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 oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% THC. Cannabis product or cannabidiol should be used primarily to treat 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 used to treat seizures (eg, tetrahydrocannabinol). * Unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia) pulmonary, hepatic (severe hepatic impairment), renal (severe renal impairment), metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality at Visit 8 of LP352-301 or LP352-302 which may impact the ability of the participant to participate or potentially confound the study results. * Is pregnant, breast-feeding, or intending to become pregnant during or within 48 hours after the last dose of study drug; or intending to donate ova during such time period. * Has a known hypersensitivity to any component of LP352 formulation or any history of serious drug-induced hypersensitivity, eg, toxic epidermal necrolysis or Drug Reaction with Eosinophilia and Systemic Symptoms. * Unwilling to abstain from donation of blood during and within 2 weeks after the study. * Is unable or unwilling to comply with any of the study requirements or timelines.

Locations (81)

Arkansas Children's Hospital - Cardiology Clinic

Little Rock, Arkansas, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

The Stanford Division of Child Neurology

Palo Alto, California, United States

UCSF Benioff Children's Hospitals - San Francisco

San Francisco, California, United States

Childrens Hospital Colorado - PIN

Aurora, Colorado, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

University of Miami - 1120 NW 14th St

Miami, Florida, United States

Research Institute of Orlando LLC

Orlando, Florida, United States

University of South Florida - 2 Tampa General Circle

Tampa, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Consultants In Epilepsy and Neurology PLLC

Boise, Idaho, United States

Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Bethesda, Maryland, United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Mayo Clinic Children's - PIN

Rochester, Minnesota, United States

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, United States

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey, United States

NYU Langone Health-NYU Comprehensive Epilepsy Center

New York, New York, United States

Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program

Portland, Oregon, United States

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas, United States

The University of Texas Medical School at Houston - UT Gastroenterology

Houston, Texas, United States

Sydney Children's Hospital - Randwick

Randwick, New South Wales, Australia

Children's Hospital at Westmead

Westmead, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

The Royal Children's Hospital (RCH) Melbourne

Parkville, Victoria, Australia

UZ Antwerpen

Edegem, Antwerp, Belgium

UZ Leuven - PPDS

Leuven, Vlaams Brabant, Belgium

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, Brazil

Instituto de Psiquiatria HC FMUSP

São Paulo, Brazil

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, Beijing Municipality, China

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, Ain, France

Hôpital Roger Salengro

Lille, Nord, France

Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer

Bron, France

AP-HM- Hôpital de La Timone

Marseille, France

AP-HP - Hôpital universitaire Necker-Enfants malades

Paris, France

AP-HP - Hôpital universitaire Robert-Debré

Paris, France

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, France

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, Lazio, Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)

Genoa, Liguria, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, Italy

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona)

Verona, Italy

IUHW Narita Hospital

Narita, Chiba, Japan

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

Dokkyo Medical University Hospital

Mibu-Machi, Tochigi, Japan

National Center Hospital, National Center of Neurology and Psychiatry

Kodaira-shi, Tokyo, Japan

Children's Clinical University Hospital

Riga, Latvia

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

Lisbon, Lisbon District, Portugal

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Porto District, Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade, Serbia

University of Belgrade-Faculty of Medicine - Clinic of Neurology and Psychiatry for Children and ...

Belgrade, Beograd, Serbia

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, Serbia

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Hospital Infantil Universitario Niño Jesus - PIN

Madrid, Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...

Valencia, Spain

NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

Glasgow, Lancashire, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)

Newcastle upon Tyne, North East, United Kingdom

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

Cardiff, South Glamorgan, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

University College London Hospitals (UCLH) - PPDS

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (81)