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RECRUITING

NCT06660394

PHASE3

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

Sponsor: Longboard Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome

Key Details

Gender

All

Age Range

2 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2024-09-25

Completion Date

2026-10-02

Last Updated

2026-08-10

Healthy Volunteers

Conditions

Dravet Syndrome

Interventions

DRUG

LP352

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

DRUG

Placebo

Participants will be administered with matching placebo orally or through G-tube/ PEG tube

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 countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic * The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening. * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. * 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. * The participant must be willing and able to provide written informed consent. Exclusion Criteria: * The participant has a history of infantile/epileptic spasms. * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. * The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing. * The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures. * The participant is receiving exclusionary medications. * The participant is currently using any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC). * The participant has 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, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. * The participant is unwilling to comply with any of the study requirements or timelines.

Locations (104)

Arkansas Children's Hospital - Cardiology Clinic

Little Rock, Arkansas, United States

Children's Hospital Los Angeles - PIN

Los Angeles, California, 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

Children's Hospital Colorado.

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Nicklaus Children's Hospital - PIN

Miami, Florida, United States

Research Institute of Orlando LLC

Orlando, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Rare Disease Research, LLC - Atlanta - RDR - PIN

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Chicago, Illinois, United States

Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Bethesda, Maryland, 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

Le Bonheur Childrens Outpatient Center - PIN

Memphis, Tennessee, United States

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas, United States

Cook Children's Jane and John Justin Neurosciences Center - PIN

Fort Worth, Texas, United States

The University of Texas Medical School at Houston - UT Gastroenterology

Houston, Texas, United States

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington, United States

Prince of Wales Hospital (POWH)

Randwick, New South Wales, Australia

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 Alfred Hospital

Melbourne, Victoria, Australia

The Royal Children's Hospital (RCH) Melbourne

Parkville, Victoria, Australia

UZ Leuven

Leuven, Vlaams Brabant, Belgium

UZ Antwerpen

Edegem, Belgium

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, Brazil

Moinhos de Vento Hospital (Hospital Moinhos de Vento) (HMV)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto do Cerebro do Rio Grande do Sul - InsCer

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, Brazil

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS

Ribeirão Preto, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, Brazil

Instituto de Psiquiatria HC FMUSP

São Paulo, Brazil

Children's and Women's Health Centre of British Columbia-4480 Oak St

Vancouver, British Columbia, Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shenzhen Children's Hospital

Shenzhen Shi, Guangdong, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, China

Filadelfia - Epilepsihospitalet (Danish Epilepsy Centre)

Dianalund, Region Sjælland, Denmark

Silmatautien Poliklinikka - Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital) L...

Kuopio, Northern Savonia, Finland

Hôpital Roger Salengro

Lille, Nord, France

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Psychiatrie

Toulouse, Occitanie, 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 Rennes - Hôpital Pontchaillou

Rennes, France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

Epilepsie-Zentrum Bodensee

Ravensburg, Germany

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Lombardy, Italy

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)

Genova, Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, Italy

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

Verona, Italy

IUHW Narita Hospital

Narita, Chiba, Japan

Fukuoka Children's Hospital (FCH)

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, 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, Rīgas Apriņķis, Latvia

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

Mexico City, Mexico City, Mexico

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Porto District, Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal

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

Lisbon, 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

University Clinical Center Kragujevac

Kragujevac, 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 Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain

Hospital Vithas Malaga

Málaga, Spain

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 Hospi...

Glasgow, United Kingdom

University College London Hospitals (UCLH) - PPDS

London, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust