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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

2026-09-15

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 (83)

Arkansas Children's Hospital - Cardiology Clinic

Little Rock, Arkansas, United States

University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro...

Los Angeles, California, United States

Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center

Palo Alto, California, United States

UCSF Benioff Children's Hospitals - San Francisco

San Francisco, California, United States

Children's Hospital Colorado - Heart Institute

Aurora, Colorado, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

University of Miami Medical Group (UMMG)

Miami, Florida, United States

Research Institute of Orlando LLC

Orlando, Florida, United States

Pediatric Epilepsy & Neurology Specialists (PENS)

Tampa, Florida, United States

University of South Florida (USF) - Tampa Campus

Tampa, Florida, United States

Consultants in Epilepsy & 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 Center - Rochester

Rochester, Minnesota, United States

Barnabas Health - Institute of Neurology and Neurosurgery

Livingston, New Jersey, United States

Northeast Regional Epilepsy Group - Morristown

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 - Austin

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

The Children's Hospital-Westmead - Heart Centre for Children

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital (RBWH)

Brisbane, Queensland, Australia

Queensland Children's Hospital (Lady Cilento Children's Hospital)

Brisbane, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

The Royal Children's Hospital (RCH) Melbourne

Parkville, Victoria, Australia

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerp, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, Brazil

Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) - Inst...

São Paulo, Brazil

Peking University First Hospital (Beida Hospital)

Beijing, Beijing Municipality, China

Capital Medical University-Beijing Children's Hospital

Beijing, Beijing Municipality, China

Guangzhou Medical University-The Second Affiliated Hospital

Guangzhou, Guangdong, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Fudan University - Children's Hospital

Shanghai Shi, Shanghai Municipality, China

Hôpital de Hautepierre - Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Ain, France

Hôpital Roger Salengro

Lille, Nord, France

Centre Hospitalier Universitaire de Lyon - Hôpital 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

Toulouse, France

Gesellschaft fuer Epilepsieforschung e.V.

Bielefeld, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Psychosomatik und Psy...

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Frankfurt - Klinikum der Goethe-Universität

Frankfurt am Main, Germany

Azienda Ospedaliero-Universitaria Meyer - Ospedale dei Bambini

Florence, Tuscany, Italy

Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare

Genoa, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, Italy

Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

Pavia, Italy

Ospedale Pediatrico Bambino Gesu - Gianicolo

Rome, Italy

Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario A Gemelli - Centro pe...

Rome, Italy

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

Verona, Italy

International University of Health and Welfare - Narita Hospital

Narita-shi, Chiba, 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

Dokkyo Medical University Hospital

Mibu-Machi, Tochigi, Japan

National Center of Neurology and Psychiatry-National Center Hospital

Kodaira-shi, Tokyo-To, Japan

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Japan

Bernu Kliniska Universitates Slimnica (BKUS) (University Children's Hospital)

Riga, Latvia

Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

Mexico City, Mexico City, Mexico

Hospital Pediátrico de Coimbra

Coimbra, Portugal

Unidade Local de Saude Santa Maria, E.P.E (ULSSM)

Lisbon, Portugal

Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)

Porto, Portugal

Univerzitetski Klinicki Centar Srbije - Klinika za Neurologiju

Belgrade, Beograd, Serbia

Institut za Zdravstvenu Zastitu Majke i Deteta Srbije Dr Vukan Cupic

Belgrade, Beograd, Serbia

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

Belgrade, Beograd, Serbia

Hospital Sant Joan de Deu Barcelona (HSJDB)

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus (HIUNJS)

Madrid, Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Cardiff and Vale University Health Board - University Hospital of Wales (UHW) - Noah's Ark Childr...

Cardiff, East Wales, United Kingdom

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

Newcastle upon Tyne, North East, United Kingdom

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

Glasgow, South Western Scotland, United Kingdom

University College London Hospitals NHS Foundation Trust (UCLH)

London, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

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 (83)