Phase
Condition
Holoprosencephaly
Autism
Dravet Syndrome
Treatment
LP352
Placebo
Clinical Study ID
Ages 2-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) mustfulfill all of the following criteria:
Onset of seizures at ≤8 years old
History of tonic/tonic-atonic seizures plus at least 1 of the following seizuretype(s): atypical absence, atonic, myoclonic, focal impaired awareness,generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms
Presence of developmental plateauing or regression
History of electroencephalogram (EEG) showing generalized slow (<2.5 Hertz [Hz]) spike-and-wave complexes
Participants who are characterized as having DEE (Other) must fulfill all of thefollowing criteria:
Does not meet criteria for LGS
Onset of seizures at ≤5 years old
Presence of developmental plateauing or regression
History of multiple seizure types
History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)
The participant has a current occurrence of at least 1 of the following countablemotor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (includinghemiclonic), and focal to bilateral tonic-clonic.
The participant has demonstrated an average of at least 4 countable motor seizuresper month for each of the 3 months prior to Screening.
The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stabledose for at least 4 weeks prior to Screening.
The participant, parent, or caregiver is willing and able (in the judgment of theinvestigator) to comply with completion of the diaries throughout the study.
The participant must be willing and able to provide written informed consent; ininstances where the participant is unable to provide consent, an appropriate legalrepresentative.
Exclusion
Exclusion Criteria:
The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of theSodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.
The participant has been admitted to a medical facility for treatment of statusepilepticus requiring mechanical ventilation within 3 months prior to Screening.
The participant has a neurodegenerative disorder as indicated by magnetic resonanceimaging or genetic testing.
The participant has an acquired lesion/injury unrelated to the primary etiology thatcould 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 notin oral solution/capsule/tablet form, not obtained from a government-approveddispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
The participant has unstable, clinically significant neurologic (other than thedisease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg,pulmonary arterial hypertension, cardiac valvulopathy, orthostatichypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal,urologic, immunologic, hematopoietic, or endocrine disease or other abnormalitywhich may impact the ability of the participant to participate or potentiallyconfound the study results.
The participant is unable or unwilling to comply with any of the study requirementsor timelines.
Study Design
Connect with a study center
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Site Number - AUS08
Randwick, New South Wales 2031
AustraliaSite Not Available
Sydney Children's Hospital
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Sydney Children's Hospital
Randwick 2208285, New South Wales 2155400 2031
AustraliaActive - Recruiting
Royal Brisbane & Women's Hospital
Herston, Queensland 4006
AustraliaActive - Recruiting
Queensland Children's Hospital
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Austin Hospital
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Royal Children's Hospital Melbourne
Parkville, Victoria 3052
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, 3004
AustraliaActive - Recruiting
UZ Antwerpen
Edegem, Antwerp 2650
BelgiumActive - Recruiting
UZ Leuven - PPDS
Leuven, 3000
BelgiumActive - Recruiting
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná 81210-310
BrazilActive - Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90035-001
BrazilActive - Recruiting
Hospital das Clinicas - UNICAMP
Campinas, São Paulo 13083-888
BrazilActive - Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo 14051-140
BrazilActive - Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo 15090-000
BrazilActive - Recruiting
Instituto de Psiquiatria HC FMUSP
São Paulo, 05403-010
BrazilActive - Recruiting
Children's and Women's Health Centre of British Columbia-4480 Oak St
Vancouver, British Columbia V6H 3V4
CanadaActive - Recruiting
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario N6A 5W9
CanadaActive - Recruiting
Hospital For Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Site Number - CAN 01
Toronto, Ontario M5G 1E8
CanadaSite Not Available
Toronto Western Hospital
Toronto, Ontario M5T 2S8
CanadaActive - Recruiting
Peking University First Hospital - Daxing Campus
Beijing, Beijing Municipality 102627
ChinaActive - Recruiting
Peking University First Hospital - Daxing Campus
Beijing 1816670, Beijing Municipality 2038349 102627
ChinaActive - Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong 510260
ChinaActive - Recruiting
Shenzhen Children's Hospital
Shenzhen, Guangdong 518000
ChinaActive - Recruiting
Wuhan Children's Hospital
Wuhan, Hubei 430010
ChinaActive - Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality 201102
ChinaActive - Recruiting
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, 100045
ChinaActive - Recruiting
Hôpital Roger Salengro
Lille, Nord 59000
FranceActive - Recruiting
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, 69500
FranceActive - Recruiting
AP-HM- Hôpital de La Timone
Marseille, 13386
FranceActive - Recruiting
AP-HP - Hôpital universitaire Robert-Debré
Paris, 75019
FranceActive - Recruiting
Hôpital Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Site Number - FRA 05
Paris, 75019
FranceSite Not Available
AP-HP - Hôpital universitaire Robert-Debré
Paris 2988507, 75019
FranceActive - Recruiting
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35203
FranceActive - Recruiting
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31330
FranceActive - Recruiting
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse 60596
GermanyActive - Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia 53127
GermanyActive - Recruiting
Epilepsiezentrum Kleinwachau gemeinnützige Gmbh
Radeberg, Saxony 01454
GermanyCompleted
Gesellschaft für Epilepsieforschung e.V.
Bielefeld, 33617
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105
GermanyActive - Recruiting
Epilepsie-Zentrum Bodensee
Ravensburg, 88214
GermanyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, 00165
Holy SeeActive - Recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio 00168
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy 20133
ItalyActive - Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy 27100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria A Meyer (Duplicate)
Florence, Tuscany 50139
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany 50139
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto 37126
ItalyActive - Recruiting
Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)
Genova, 16147
ItalyActive - Recruiting
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genova, 16147
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, 00165
ItalyActive - Recruiting
Site Number - ITA 06
Roma, 00165
ItalySite Not Available
IUHW Narita Hospital
Narita, Chiba 286-8520
JapanActive - Recruiting
Fukuoka Children's Hospital
Fukuoka, Fukuoka 813-0017
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo, Hokkaidô 060-8648
JapanActive - Recruiting
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata 950-2074
JapanActive - Recruiting
Okayama University Hospital
Okayama, Okayama-ken 700-8558
JapanActive - Recruiting
Osaka City General Hospital
Osaka-Shi Miyakojima-Ku, Osaka 534-0021
JapanActive - Recruiting
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama 330-8777
JapanActive - Recruiting
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka 420-0953
JapanActive - Recruiting
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo 187-8502
JapanActive - Recruiting
Dokkyo Medical University Hospital
Mibu-Machi, 321-0293
JapanActive - Recruiting
Children's Clinical University Hospital
Riga, Rīgas Apriņķis LV-1004
LatviaActive - Recruiting
Site Number - MEX 01
Mexico City, Cdmx 04530
MexicoSite Not Available
Universitair Medisch Centrum Utrecht - PPDS
Utrecht, 3584 CX
NetherlandsActive - Recruiting
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, 3000-602
PortugalActive - Recruiting
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, 1649-035
PortugalActive - Recruiting
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto, 4050-651
PortugalActive - Recruiting
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade, Belgrade 11000
SerbiaActive - Recruiting
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade 792680, Belgrade 11000
SerbiaActive - Recruiting
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, 11000
SerbiaActive - Recruiting
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, 190133
SerbiaActive - Recruiting
Site number - SRB 06
Belgrade, 11000
SerbiaActive - Recruiting
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade 792680, 190133
SerbiaActive - Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona 08950
SpainActive - Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga 29010
SpainActive - Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga 2514256, Málaga 29010
SpainActive - Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre 31008
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
SpainActive - Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
SpainActive - Recruiting
Site number - ESP 05
Barcelona, 08035
SpainSite Not Available
Site number - ESP 12
Barcelona, 08950
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, 28009
SpainActive - Recruiting
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, 28010
SpainActive - Recruiting
Site number - ESP 03
Madrid, 28034
SpainSite Not Available
Site number - ESP 10
Madrid, 28009
SpainSite Not Available
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid 3117735, 28034
SpainActive - Recruiting
Hospital Universitario Vithas Madrid La Milagrosa
Madrid 3117735, 28010
SpainActive - Recruiting
Hospital Vithas Malaga
Málaga, 29016
SpainActive - Recruiting
Site number - ESP 09
Málaga, 29016
SpainSite Not Available
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainActive - Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, Northamptonshire NE1 4LP
United KingdomActive - Recruiting
Noah's Ark Children's Hospital for Wales - PIN
Cardiff, South Glamorgan CF14 4XW
United KingdomActive - Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
United KingdomActive - Recruiting
Queen Elizabeth University Hospital - PPDS
Glasgow, G51 4TF
United KingdomActive - Recruiting
Great Ormond Street Hospital - PPDS
London, WC1N 3JH
United KingdomActive - Recruiting
Site number - GBR 03
London, WC1N 3BH
United KingdomSite Not Available
University College London Hospitals (UCLH) - PPDS
London, NW1 2PG
United KingdomActive - Recruiting
University College London Hospitals (UCLH) - PPDS
London 2643743, NW1 2PG
United KingdomActive - Recruiting
Southampton General Hospital
Southampton, SO16 6YD
United KingdomActive - Recruiting
Arkansas Children's Hospital - PIN
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202
United StatesActive - Recruiting
Children's Hospital Los Angeles - PIN
Los Angeles, California 90027-6062
United StatesActive - Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California 90095-3075
United StatesActive - Recruiting
Site Number - USA26
Los Angeles, California 90027
United StatesSite Not Available
The Stanford Division of Child Neurology
Palo Alto, California 94304-1510
United StatesActive - Recruiting
UCSF Children's Hospital
San Francisco, California 94143-2350
United StatesActive - Recruiting
David Geffen School of Medicine at UCLA
Los Angeles 5368361, California 5332921 90095-8346
United StatesActive - Recruiting
Children's Hospital Colorado.
Aurora, Colorado 80045-7106
United StatesActive - Recruiting
Children's National Medical Center
Washington D.C., District of Columbia 20010-2916
United StatesActive - Recruiting
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida 32561-4458
United StatesActive - Recruiting
Site Number - USA02
Gulf Breeze, Florida 32561
United StatesActive - Recruiting
Nicklaus Children's Hospital - PIN
Miami, Florida 33155-3009
United StatesActive - Recruiting
University of Miami - 1120 NW 14th St
Miami, Florida 33136-2107
United StatesActive - Recruiting
Research Institute of Orlando LLC
Orlando, Florida 32806-5411
United StatesCompleted
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33609-4190
United StatesActive - Recruiting
Site Number - USA11
Tampa, Florida 33609
United StatesActive - Recruiting
University of South Florida - 2 Tampa General Circle
Tampa, Florida 33606
United StatesActive - Recruiting
Nicklaus Children's Hospital - PIN
Miami 4164138, Florida 4155751 33155-3009
United StatesActive - Recruiting
Pediatric Epilepsy and Neurology Specialists
Tampa 4174757, Florida 4155751 33609-4190
United StatesActive - Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN
Atlanta, Georgia 30329
United StatesActive - Recruiting
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, Georgia 30329
United StatesCompleted
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta 4180439, Georgia 4197000 30329
United StatesCompleted
Consultants In Epilepsy and Neurology PLLC
Boise, Idaho 83702-5029
United StatesActive - Recruiting
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago, Illinois 60611-5975
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa 52242-1009
United StatesActive - Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817-1844
United StatesActive - Recruiting
Massachusetts General Hospital - 175 Cambridge St
Boston, Massachusetts 02114
United StatesActive - Recruiting
Site Number - USA 40
Boston, Massachusetts 02215
United StatesSite Not Available
Site Number - USA30
Boston, Massachusetts 02114
United StatesSite Not Available
Mayo Clinic - PIN
Rochester, Minnesota 55905-0001
United StatesActive - Recruiting
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey 07039-5817
United StatesActive - Recruiting
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown, New Jersey 07960
United StatesActive - Recruiting
Site Number - USA36
Morristown, New Jersey 07961
United StatesSite Not Available
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York 10016-4852
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239-3011
United StatesActive - Recruiting
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee 38103-2816
United StatesActive - Recruiting
Le Bonheur Childrens Hospital
Memphis 4641239, Tennessee 4662168 38103-2816
United StatesActive - Recruiting
Le Bonheur Childrens Outpatient Center - PIN
Memphis 4641239, Tennessee 4662168 38103-2816
United StatesActive - Recruiting
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas 78757
United StatesActive - Recruiting
Site Number - USA 41
Austin, Texas 78757
United StatesSite Not Available
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas 76104-2710
United StatesActive - Recruiting
The University of Texas Medical School at Houston
Houston, Texas 77030
United StatesActive - Recruiting
Child Neurology Consultants of Austin
Austin 4671654, Texas 4736286 78757
United StatesActive - Recruiting
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth 4691930, Texas 4736286 76104-2710
United StatesActive - Recruiting
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington 98405-4048
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.