Phase
Condition
Dravet Syndrome
Epilepsy
Neurologic Disorders
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 has used of any cannabis product or cannabidiol that is not in oralsolution/capsule/tablet form, not obtained from a government-approved dispensary, orcontains ≥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
Site Number - AUS07
Randwick, New South Wales 2031
AustraliaSite Not Available
Site Number - AUS08
Randwick, New South Wales 2031
AustraliaSite Not Available
Site Number - AUS 09
Westmead, New South Wales 2145
AustraliaSite Not Available
Site Number - AUS04
Herston, Queensland 4006
AustraliaSite Not Available
Site Number - AUS05
South Brisbane, Queensland 4101
AustraliaSite Not Available
Site Number - AUS02
Heidelberg, Victoria 3084
AustraliaSite Not Available
Site Number - AUS03
Melbourne, Victoria 3004
AustraliaSite Not Available
Site Number - AUS 06
Parkville, Victoria 3052
AustraliaSite Not Available
Site Number - BEL 01
Edegem, 2650
BelgiumSite Not Available
Site Number - BEL 02
Leuven, 3000
BelgiumSite Not Available
Site Number - BRA 01
Curitiba, PR 81210-310
BrazilSite Not Available
Site Number - BRA 02
Ribeirão Preto, SP 14015-010
BrazilSite Not Available
Site Number - BRA 05
São José Do Rio Preto, SP 15090-000
BrazilSite Not Available
Site Number - BRA 03
São Paulo, SP 05403-903
BrazilSite Not Available
Site Number - CAN 04
Vancouver, British Columbia V5Z 4H4
CanadaSite Not Available
Site Number - CAN 01
Toronto, Ontario M5G 1E8
CanadaSite Not Available
Site Number - CAN 03
Toronto, Ontario M5T 0S8
CanadaSite Not Available
Site Number - CHN 01
Beijing, 100034
ChinaSite Not Available
Site Number - FRA 08
Bron, 69500
FranceSite Not Available
Site Number - FRA 04
Lille, 59037
FranceSite Not Available
Site Number - FRA 06
Marseille, 13005
FranceSite Not Available
Site Number - FRA 05
Paris, 75019
FranceSite Not Available
Site Number - FRA 09
Paris, 75015
FranceSite Not Available
Site Number - FRA 01
Rennes, 35000
FranceSite Not Available
Site Number - FRA 07
Strasbourg, 67200
FranceSite Not Available
Site Number - FRA 03
Toulouse, 31300
FranceSite Not Available
Site Number - DEU 02
Bielefeld, 33617
GermanySite Not Available
Site Number - DEU 07
Bonn, 53127
GermanySite Not Available
Site Number - DEU 01
Frankfurt, 60596
GermanySite Not Available
Site Number - DEU 04
Freiburg im Breisgau, 79106
GermanySite Not Available
Site Number - DEU 03
Kiel, 24105
GermanySite Not Available
Site Number - DEU 06
Radeberg, 01454
GermanySite Not Available
Site Number - DEU 05
Ravensburg, 88214
GermanySite Not Available
Site Number - ITA 03
Genova, 16147
ItalySite Not Available
Site Number - ITA 07
Milan, 20133
ItalySite Not Available
Site Number - ITA 02
Pavia, 27100
ItalySite Not Available
Site Number - ITA 01
Roma, 00168
ItalySite Not Available
Site Number - ITA 06
Roma, 00165
ItalySite Not Available
Site Number - ITA 04
Toscana, 50139
ItalySite Not Available
Site Number - ITA 08
Verona, 37126
ItalySite Not Available
Site Number - LVA 01
Riga, 1004
LatviaSite Not Available
Site Number - MEX 01
Mexico City, Cdmx 04530
MexicoSite Not Available
Site Number - MEX 02
Mexico City, 06720
MexicoSite Not Available
Site Number - NLD 02
Zwolle, BV 8025
NetherlandsSite Not Available
Site Number - NLD 03
Utrecht, CX 3584
NetherlandsSite Not Available
Site Number - PRT 02
Coimbra, 3004-561
PortugalSite Not Available
Site Number - PRT 03
Lisbon, 1649-028
PortugalSite Not Available
Site Number - PRT 05
Porto Covo, 4050-651
PortugalSite Not Available
Site Number - SRB 02
Belgrade, 11070
SerbiaSite Not Available
Site number - SRB 06
Belgrade, 11000
SerbiaSite Not Available
Site Number - SRB 03
Kragujevac, 34000
SerbiaSite Not Available
Site number - ESP 02
Barcelona, 8025
SpainSite Not Available
Site number - ESP 05
Barcelona, 08035
SpainSite Not Available
Site number - ESP 12
Barcelona, 08950
SpainSite Not Available
Site number - ESP 03
Madrid, 28034
SpainSite Not Available
Site number - ESP 10
Madrid, 28009
SpainSite Not Available
Site number - ESP 11
Madrid, 28010
SpainSite Not Available
Site number - ESP 04
Málaga, 29010
SpainSite Not Available
Site number - ESP 09
Málaga, 29016
SpainSite Not Available
Site number - ESP 06
Pamplona, 31009
SpainSite Not Available
Site number - ESP 08
Valencia, 46026
SpainSite Not Available
Site number - GBR 01
Birmingham, B15 2GW
United KingdomSite Not Available
Site number - GBR 04
Glasgow, G51 4TF
United KingdomSite Not Available
Site number - GBR 03
London, WC1N 3BH
United KingdomSite Not Available
Site number - GBRXX
London, NW1 2BU
United KingdomSite Not Available
Site number - GBR 05
Newcastle Upon Tyne, NE1 4LP
United KingdomSite Not Available
Site number - GBR 02
Southampton, SO16 6YD
United KingdomSite Not Available
Site Number - USA19
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Site Number - USA29
La Jolla, California 92037
United StatesSite Not Available
Site Number - USA18
Los Angeles, California 90095
United StatesSite Not Available
Site Number - USA26
Los Angeles, California 90027
United StatesSite Not Available
Site Number - USA24
Palo Alto, California 94304
United StatesSite Not Available
Site Number - USA28
San Francisco, California 94904
United StatesSite Not Available
Site Number - USA17
Aurora, Colorado 80045
United StatesActive - Recruiting
Site Number - USA02
Gulf Breeze, Florida 32806
United StatesActive - Recruiting
Site Number - USA37
Miami, Florida 33155
United StatesSite Not Available
Site Number - USA05
Orlando, Florida 32806
United StatesActive - Recruiting
Site Number - USA 08
Tampa, Florida 33606
United StatesSite Not Available
Site Number - USA11
Tampa, Florida 33609
United StatesActive - Recruiting
Site Number - USA09
Atlanta, Georgia 30329
United StatesTerminated
Site Number - USA38
Chicago, Illinois 60611
United StatesSite Not Available
Site Number - USA 13
Iowa City, Iowa 52242
United StatesSite Not Available
Site Number - USA07
Bethesda, Maryland 20817
United StatesActive - Recruiting
Site Number - USA 40
Boston, Massachusetts 02215
United StatesSite Not Available
Site Number - USA30
Boston, Massachusetts 02114
United StatesSite Not Available
Site Number - USA40
Boston, Massachusetts 02215
United StatesSite Not Available
Site Number - USA15
Rochester, Minnesota 55905
United StatesSite Not Available
Site Number - USA10
Livingston, New Jersey 07039
United StatesActive - Recruiting
Site Number - USA36
Morristown, New Jersey 07601
United StatesActive - Recruiting
Site Number - USA32
New York, New York 10016
United StatesSite Not Available
Site Number - USA14
Cincinnati, Ohio 45229
United StatesSite Not Available
Site Number - USA39
Cleveland, Ohio 44195
United StatesSite Not Available
Site Number - USA35
Columbus, Ohio 43205
United StatesSite Not Available
Site Number - USA33
Portland, Oregon 97239
United StatesSite Not Available
Site Number - USA22
Charleston, South Carolina 29425
United StatesSite Not Available
Site Number - USA34
Memphis, Tennessee 38103
United StatesSite Not Available
Site Number - USA 41
Austin, Texas 78757
United StatesSite Not Available
Site Number - USA41
Austin, Texas 78757
United StatesActive - Recruiting
Site Number - USA31
Fort Worth, Texas 76104
United StatesSite Not Available
Site Number - USA25
Houston, Texas 77030
United StatesActive - Recruiting
Site Number - USA03
Tacoma, Washington 98405
United StatesActive - Recruiting
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