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NCT06660394PHASE3Recruiting

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

Longboard Pharmaceuticals

Start Date

9/25/2024

Completion Date

10/2/2026

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.

Eligibility Criteria

Age Range: 2 years to 65 years

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.

Interventions

DRUG

LP352

DRUG

Placebo

Interested in This Trial?

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Conditions

Dravet Syndrome

Locations

Arkansas Children's Hospital - PIN

Little Rock, Arkansas 72202-3500

United States

Children's Hospital Los Angeles - PIN

Los Angeles, California 90027-6062

United States

David Geffen School of Medicine at UCLA

Los Angeles, California 90095-3075

United States

The Stanford Division of Child Neurology

Palo Alto, California 94304-1510

United States

UCSF Children's Hospital

San Francisco, California 94143-2350

United States

Children's Hospital Colorado.

Aurora, Colorado 80045-7106

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida 32561-4458

United States

Nicklaus Children's Hospital - PIN

Miami, Florida 33155-3009

United States

Research Institute of Orlando LLC

Orlando, Florida 32806-5411

United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida 33609-4190

United States

Rare Disease Research, LLC - Atlanta - RDR - PIN

Atlanta, Georgia 30329

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611-5975

United States

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Chicago, Illinois 60611

United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland 20817-1844

United States

Mayo Clinic - PIN

Rochester, Minnesota 55905-0001

United States

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey 07039-5817

United States

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey 07960

United States

NYU Comprehensive Epilepsy Center - BRANY - PPDS

New York, New York 10016-4852

United States

Oregon Health and Science University

Portland, Oregon 97239-3011

United States

Le Bonheur Childrens Outpatient Center - PIN

Memphis, Tennessee 38103-2816

United States

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas 78757

United States

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

Fort Worth, Texas 76104-2710

United States

The University of Texas Medical School at Houston

Houston, Texas 77030

United States

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington 98405

United States

Prince of Wales Hospital

Randwick, New South Wales 2031

Australia

Sydney Children's Hospital

Randwick, New South Wales 2031

Australia

Children's Hospital at Westmead

Westmead, New South Wales 2145

Australia

Royal Brisbane & Women's Hospital

Herston, Queensland 4029

Australia

Queensland Children's Hospital

South Brisbane, Queensland 4101

Australia

Austin Hospital

Heidelberg, Victoria 3084

Australia

Royal Children's Hospital Melbourne

Parkville, Victoria 3052

Australia

The Alfred Hospital

Melbourne, 3004

Australia

UZ Leuven

Leuven, Vlaams Brabant 3000

Belgium

UZ Antwerpen

Antwerp, 2650

Belgium

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná 81210-310

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul 90035-001

Brazil

Instituto do Cerebro do Rio Grande do Sul - InsCer

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Hospital das Clinicas - UNICAMP

Campinas, São Paulo 13083-888

Brazil

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

Ribeirão Preto, São Paulo 14051-140

Brazil

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

São José do Rio Preto, São Paulo 15090-000

Brazil

Instituto de Psiquiatria HC FMUSP

São Paulo, 05403-010

Brazil

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

Vancouver, British Columbia V6H 3V4

Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario N6A 5W9

Canada

Hospital For Sick Children

Toronto, Ontario M5G 1X8

Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality 102627

China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510260

China

Shenzhen Children's Hospital

Shenzhen, Guangdong 518000

China

Wuhan Children's Hospital

Wuhan, Hubei 430010

China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality 201102

China

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, 100045

China

Hôpital Roger Salengro

Lille, Nord 59000

France

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, 69500

France

AP-HM- Hôpital de La Timone

Marseille, 13386

France

Hôpital Necker - Enfants Malades

Paris, 75015

France

AP-HP - Hôpital universitaire Robert-Debré

Paris, 75019

France

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35203

France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098

France

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31330

France

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse 60596

Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia 53127

Germany

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, 33617

Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105

Germany

Epilepsie-Zentrum Bodensee

Ravensburg, 88214

Germany

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio 00168

Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy 27100

Italy

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany 50139

Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto 37126

Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)

Genova, 16147

Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165

Italy

IUHW Narita Hospital

Narita-shi, Chiba 286-8520

Japan

Fukuoka Children's Hospital

Fukuoka, Fukuoka 813-0017

Japan

Hokkaido University Hospital

Sapporo, Hokkaidô 060-8648

Japan

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata 950-2074

Japan

Okayama University Hospital

Okayama, Okayama-ken 700-8558

Japan

Osaka City General Hospital

Osaka-Shi Miyakojima-Ku, Osaka 534-0021

Japan

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama 330-8777

Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka 420-0953

Japan

Dokkyo Medical University Hospital

Mibu-Machi, Tochigi 321-0293

Japan

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo 187-8502

Japan

Children's Clinical University Hospital

Riga, Rīgas Apriņķis LV-1004

Latvia

Instituto Nacional de Pediatría

Mexico City, 4530

Mexico

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602

Portugal

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

Lisbon, 1649-035

Portugal

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto, 4050-651

Portugal

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade 11000

Serbia

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, 11000

Serbia

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, 11000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona 08950

Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga 29010

Spain

Hospital Universitario de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035

Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, 8041

Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, 28010

Spain

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, 28034

Spain

Hospital Vithas Malaga

Málaga, 29016

Spain

Royal Victoria Infirmary

Newcastle upon Tyne, Northamptonshire NE1 4LP

United Kingdom

Queen Elizabeth University Hospital - PPDS

Glasgow, G51 4TF

United Kingdom

University College London Hospitals (UCLH) - PPDS

London, NW1 2PG

United Kingdom

Great Ormond Street Hospital - PPDS

London, WC1N 3JH

United Kingdom