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ACTIVE NOT 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

96

Start Date

2024-09-25

Completion Date

2026-12-31

Last Updated

2026-09-17

Healthy Volunteers

No

Conditions

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

Locations (105)

Arkansas Children's Hospital - Cardiology Clinic

Little Rock, Arkansas, United States

Children's Hospital Los Angeles (CHLA)

Los Angeles, California, 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

Children's National Hospital - Children's National Heart Center

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

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Nicklaus Children's Hospital (Miami Children's Hospital)

Miami, Florida, United States

Research Institute of Orlando LLC

Orlando, Florida, United States

Pediatric Epilepsy & Neurology Specialists (PENS)

Tampa, Florida, United States

Rare Disease Research, LLC. (RDR)

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Northwestern University - Ann & Robert H. Lurie Children's Hospital of Chicago - Center for Cance...

Chicago, Illinois, United States

Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Bethesda, Maryland, 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

Le Bonheur Children's Hospital - Outpatient Center

Memphis, Tennessee, United States

Child Neurology Consultants of Austin - Austin

Austin, Texas, United States

Cook Children's Jane and John Justin Neurosciences Center

Fort Worth, Texas, United States

The University of Texas Medical School at Houston - UT Gastroenterology

Houston, Texas, United States

MultiCare Health System

Tacoma, Washington, United States

Prince of Wales Hospital (POWH)

Randwick, New South Wales, Australia

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 Alfred Hospital

Melbourne, 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

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

Porto Alegre, Rio Grande do Sul, Brazil

Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Instituto Do Cerebro Do Rio Grand...

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Estadual de Campinas (UNICAMP) - Hospital das Clinicas (HC)

Campinas, São Paulo, Brazil

Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto ...

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP)

São José do Rio Preto, São Paulo, Brazil

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

São Paulo, Brazil

BC Children's Hospital (British Columbia Children's Hospital)

Vancouver, British Columbia, Canada

London Health Sciences Centre (LHSC)

London, Ontario, Canada

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC)

Toronto, Ontario, Canada

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

Shenzhen Children's Hospital

Shenzhen Shi, Guangdong, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Fudan University - Children's Hospital

Shanghai Shi, Shanghai Municipality, China

Aarhus Universitetshospital

Aarhus, Central Jutland, Denmark

Filadelfia - Epilepsihospitalet (Danish Epilepsy Centre)

Dianalund, Region Sjælland, Denmark

Helsingin Yliopistollinen Keskussairaala (HYKS) - Uusi Lastensairaala

Helsinki, Uusimaa, Finland

Hôpital Roger Salengro

Lille, Nord, France

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

Toulouse, Occitanie, 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

Hôpital de Hautepierre - Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Chu de Rennes - Centre d'Evaluation et de Traitement de la Douleur de l'Adulte et de l'Enfant

Villejuif, Île-de-France Region, France

Universitätsklinikum Frankfurt - Klinikum der Goethe-Universität

Frankfurt am Main, Hesse, Germany

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

Epilepsie-Zentrum Bodensee

Ravensburg, Germany

Azienda Ospedaliero-Universitaria Meyer - Ospedale dei Bambini

Florence, Tuscany, Italy

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

Genoa, 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

Fukuoka Children's Hospital (FCH)

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, 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

Clinical Center Kragujevac

Kragujevac, Sumadijski Okrug, 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 Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, 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 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