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