Dravet Syndrome Clinical Trials

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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

Status: Recruiting
Location: See all (104) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 65
Healthy Volunteers: f
View:

• Diagnosis of DS must fulfill all of the following criteria:

‣ Participants with seizure onset age \>1 and \<20 months

⁃ 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.

Locations
United States
Arkansas
Arkansas Children's Hospital - Cardiology Clinic
RECRUITING
Little Rock
California
Children's Hospital Los Angeles - PIN
RECRUITING
Los Angeles
David Geffen School of Medicine at UCLA
RECRUITING
Los Angeles
The Stanford Division of Child Neurology
RECRUITING
Palo Alto
UCSF Benioff Children's Hospitals - San Francisco
COMPLETED
San Francisco
Colorado
Children's Hospital Colorado.
RECRUITING
Aurora
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
NW FL Clinical Research Group, LLC
RECRUITING
Gulf Breeze
Nicklaus Children's Hospital - PIN
RECRUITING
Miami
Research Institute of Orlando LLC
COMPLETED
Orlando
Pediatric Epilepsy and Neurology Specialists
RECRUITING
Tampa
Georgia
Rare Disease Research, LLC - Atlanta - RDR - PIN
COMPLETED
Atlanta
Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
RECRUITING
Chicago
Northwestern Memorial Hospital
RECRUITING
Chicago
Maryland
Mid-Atlantic Epilepsy and Sleep Center - Bethesda
RECRUITING
Bethesda
Minnesota
Mayo Clinic Children's - PIN
RECRUITING
Rochester
New Jersey
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
RECRUITING
Livingston
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
RECRUITING
Morristown
New York
NYU Langone Health-NYU Comprehensive Epilepsy Center
RECRUITING
New York
Oregon
Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program
RECRUITING
Portland
Tennessee
Le Bonheur Childrens Outpatient Center - PIN
RECRUITING
Memphis
Texas
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
RECRUITING
Austin
Cook Children's Jane and John Justin Neurosciences Center - PIN
RECRUITING
Fort Worth
The University of Texas Medical School at Houston - UT Gastroenterology
RECRUITING
Houston
Washington
Multicare Health System - Mary Bridge Pediatrics
RECRUITING
Tacoma
Other Locations
Australia
Austin Hospital
RECRUITING
Heidelberg
Royal Brisbane & Women's Hospital
RECRUITING
Herston
The Alfred Hospital
RECRUITING
Melbourne
The Royal Children's Hospital (RCH) Melbourne
RECRUITING
Parkville
Prince of Wales Hospital (POWH)
RECRUITING
Randwick
Sydney Children's Hospital - Randwick
RECRUITING
Randwick
Queensland Children's Hospital
RECRUITING
South Brisbane
Children's Hospital at Westmead
RECRUITING
Westmead
Belgium
UZ Antwerpen
RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
Brazil
Hospital das Clinicas - UNICAMP
RECRUITING
Campinas
Instituto de Neurologia de Curitiba (INC)
RECRUITING
Curitiba
Instituto do Cerebro do Rio Grande do Sul - InsCer
RECRUITING
Porto Alegre
Moinhos de Vento Hospital (Hospital Moinhos de Vento) (HMV)
RECRUITING
Porto Alegre
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
RECRUITING
Ribeirão Preto
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
RECRUITING
São José Do Rio Preto
Instituto de Psiquiatria HC FMUSP
RECRUITING
São Paulo
Canada
London Health Sciences Centre -800 Commissioners Rd E
RECRUITING
London
The Hospital for Sick Children (SickKids)
RECRUITING
Toronto
Toronto Western Hospital
RECRUITING
Toronto
Children's and Women's Health Centre of British Columbia-4480 Oak St
RECRUITING
Vancouver
China
Beijing Children's Hospital, Capital Medical University - PIN
RECRUITING
Beijing
Peking University First Hospital - Daxing Campus
RECRUITING
Beijing
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Children's Hospital of Fudan University
RECRUITING
Shanghai
Shenzhen Children's Hospital
RECRUITING
Shenzhen Shi
Wuhan Children's Hospital
RECRUITING
Wuhan
Denmark
Filadelfia - Epilepsihospitalet (Danish Epilepsy Centre)
RECRUITING
Dianalund
Finland
Silmatautien Poliklinikka - Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital) L...
RECRUITING
Kuopio
France
Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer
RECRUITING
Bron
Hôpital Roger Salengro
RECRUITING
Lille
AP-HM- Hôpital de La Timone
RECRUITING
Marseille
AP-HP - Hôpital universitaire Necker-Enfants malades
RECRUITING
Paris
AP-HP - Hôpital universitaire Robert-Debré
RECRUITING
Paris
CHU de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
CHU de Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Psychiatrie
RECRUITING
Toulouse
Germany
Gesellschaft für Epilepsieforschung e.V.
RECRUITING
Bielefeld
Universitätsklinikum Bonn
RECRUITING
Bonn
Klinikum der Johann-Wolfgang Goethe-Universitat
RECRUITING
Frankfurt Am Main
Universitätsklinikum Schleswig-Holstein - Campus Kiel
RECRUITING
Kiel
Epilepsie-Zentrum Bodensee
RECRUITING
Ravensburg
Italy
Azienda Ospedaliero Universitaria A Meyer (Duplicate)
RECRUITING
Florence
Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)
RECRUITING
Genova
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
RECRUITING
Pavia
IRCCS Ospedale Pediatrico Bambino Gesu
RECRUITING
Roma
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
RECRUITING
Rome
Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona)
RECRUITING
Verona
Japan
Fukuoka Children's Hospital (FCH)
RECRUITING
Fukuoka
National Center Hospital, National Center of Neurology and Psychiatry
RECRUITING
Kodaira-shi
Dokkyo Medical University Hospital
RECRUITING
Mibu-machi
IUHW Narita Hospital
RECRUITING
Narita
National Hospital Organization Nishi-Niigata Chuo National Hospital
RECRUITING
Niigata
Okayama University Hospital
RECRUITING
Okayama
Osaka City General Hospital
RECRUITING
Osaka
Saitama Prefectural Children's Medical Center
RECRUITING
Saitama-shi
Hokkaido University Hospital
RECRUITING
Sapporo
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
RECRUITING
Shizuoka
Latvia
Children's Clinical University Hospital
RECRUITING
Riga
Mexico
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
RECRUITING
Mexico City
Portugal
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
RECRUITING
Coimbra
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
RECRUITING
Lisbon
ULS de Santo António, EPE - Centro Materno Infantil Norte
RECRUITING
Porto Covo
Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
RECRUITING
Belgrade
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
RECRUITING
Belgrade
University of Belgrade-Faculty of Medicine - Clinic of Neurology and Psychiatry for Children and ...
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Spain
Hospital de la Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital Sant Joan de Deu - PIN
RECRUITING
Espluges De Llobregat
Hospital Ruber Internacional (Grupo Quironsalud)
RECRUITING
Madrid
Hospital Universitario Vithas Madrid La Milagrosa
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Hospital Vithas Malaga
RECRUITING
Málaga
Hospital Universitario de Navarra
RECRUITING
Pamplona
United Kingdom
NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
RECRUITING
Glasgow
Great Ormond Street Hospital for Children NHS Foundation Trust
RECRUITING
London
University College London Hospitals (UCLH) - PPDS
RECRUITING
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Email contact via H. Lundbeck A/S
HQ_Medinfo@Lundbeck.com
+45 36301311
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2026-10-02
Participants
Target number of participants: 104
Treatments
Experimental: LP352
Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.
Placebo_comparator: Placebo
Placebo for LP352
Sponsors
Leads: Longboard Pharmaceuticals

This content was sourced from clinicaltrials.gov