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A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Sponsor: Longboard Pharmaceuticals
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
LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
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