Clinical trial NCT06660394: A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dravet Syndrome
Keywords: Antiseizure medication
Epilepsy
Neurodevelopmental disorders
Developmental and epileptic encephalopathy
LP352
Seizures
DEEp SEA
Bexicaserin
Lead sponsor: Longboard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: Inclusion Criteria:

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

  1. Participants with seizure onset age \>1 and \<20 months
  2. 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.

Exclusion Criteria:

* The participant has a history of infantile/epileptic spasms.
* The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
* The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
* The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
* The participant is receiving exclusionary medications.
* The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
* The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
* The participant is unwilling to comply with any of the study requirements or timelines.

Primary outcomes:
measure: Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
timeFrame: Baseline and up to 15 Weeks
Secondary outcomes:
measure: Safety and Tolerability of LP352
timeFrame: Up to 21 Weeks
measure: Percentage of participants with ≥ 50% Reduction in countable motor seizures during Treatment compared to Baseline
timeFrame: Baseline and up to 15 Weeks
measure: Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline
timeFrame: Baseline and up to 15 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Number - USA19
state: Arkansas
city: La Jolla
country: United States
facility: Site Number - USA29
state: California
city: Los Angeles
country: United States
facility: Site Number - USA26
state: California
city: Los Angeles
country: United States
facility: Site Number - USA18
state: California
city: Palo Alto
country: United States
facility: Site Number - USA24
state: California
city: San Francisco
country: United States
facility: Site Number - USA28
state: California
city: Aurora
country: United States
facility: Site Number - USA17
state: Colorado
city: Gulf Breeze
country: United States
facility: Site Number - USA02
state: Florida
city: Miami
country: United States
facility: Site Number - USA37
state: Florida
city: Orlando
country: United States
facility: Site Number - USA05
state: Florida
city: Tampa
country: United States
facility: Site Number - USA11
state: Florida
city: Atlanta
country: United States
facility: Site Number - USA09
state: Georgia
city: Chicago
country: United States
facility: Site Number - USA38
state: Illinois
city: Bethesda
country: United States
facility: Site Number - USA07
state: Maryland
city: Boston
country: United States
facility: Site Number - USA40
state: Massachusetts
city: Rochester
country: United States
facility: Site Number - USA15
state: Minnesota
city: Livingston
country: United States
facility: Site Number - USA10
state: New Jersey
city: Morristown
country: United States
facility: Site Number - USA36
state: New Jersey
city: New York
country: United States
facility: Site Number - USA32
state: New York
city: Cincinnati
country: United States
facility: Site Number - USA14
state: Ohio
city: Cleveland
country: United States
facility: Site Number - USA39
state: Ohio
city: Columbus
country: United States
facility: Site Number - USA35
state: Ohio
city: Portland
country: United States
facility: Site Number - USA33
state: Oregon
city: Charleston
country: United States
facility: Site Number - USA22
state: South Carolina
city: Memphis
country: United States
facility: Site Number - USA34
state: Tennessee
city: Austin
country: United States
facility: Site Number - USA41
state: Texas
city: Fort Worth
country: United States
facility: Site Number - USA31
state: Texas
city: Houston
country: United States
facility: Site Number - USA25
state: Texas
city: Tacoma
country: United States
facility: Site Number - USA03
state: Washington
city: Randwick
country: Australia
facility: Site Number - AUS07
state: New South Wales
city: Randwick
country: Australia
facility: Site Number - AUS08
state: New South Wales
city: Westmead
country: Australia
facility: Site Number - AUS09
state: New South Wales
city: Herston
country: Australia
facility: Site Number - AUS04
state: Queensland
city: South Brisbane
country: Australia
facility: Site Number - AUS05
state: Queensland
city: Heidelberg
country: Australia
facility: Site Number - AUS02
state: Victoria
city: Melbourne
country: Australia
facility: Site Number - AUS03
state: Victoria
city: Parkville
country: Australia
facility: Site Number - AUS06
state: Victoria
city: Edegem
country: Belgium
facility: Site Number - BEL01
city: Leuven
country: Belgium
facility: Site Number - BEL02
city: Ribeirão Preto
country: Brazil
facility: Site Number - BRA02
state: SP
city: São José Do Rio Preto
country: Brazil
facility: Site Number - BRA05
state: SP
city: São Paulo
country: Brazil
facility: Site Number - BRA03
state: SP
city: Curitiba
country: Brazil
facility: Site Number - BRA01
city: Vancouver
country: Canada
facility: Site Number - CAN04
state: British Columbia
city: Toronto
country: Canada
facility: Site Number - CAN01
state: Ontario
city: Toronto
country: Canada
facility: Site Number - CAN03
state: Ontario
city: Beijing
country: China
facility: Site Number - CHN01
city: Bron
country: France
facility: Site Number - FRA08
city: Lille
country: France
facility: Site Number - FRA04
city: Marseille
country: France
facility: Site Number - FRA06
city: Paris
country: France
facility: Site Number - FRA09
city: Paris
country: France
facility: Site Number - FRA05
city: Rennes
country: France
facility: Site Number - FRA01
city: Strasbourg
country: France
facility: Site Number - FRA07
city: Toulouse
country: France
facility: Site Number - FRA03
city: Bielefeld
country: Germany
facility: Site Number - DEU02
city: Bonn
country: Germany
facility: Site Number - DEU07
city: Frankfurt
country: Germany
facility: Site Number - DEU01
city: Freiburg im Breisgau
country: Germany
facility: Site Number - DEU04
city: Kiel
country: Germany
facility: Site Number - DEU03
city: Radeberg
country: Germany
facility: Site Number - DEU06
city: Ravensburg
country: Germany
facility: Site Number - DEU05
city: Genova
country: Italy
facility: Site Number - ITA03
city: Pavia
country: Italy
facility: Site Number - ITA02
city: Roma
country: Italy
facility: Site Number - ITA06
city: Roma
country: Italy
facility: Site Number - ITA01
city: Toscana
country: Italy
facility: Site Number - ITA04
city: Verona
country: Italy
facility: Site Number - ITA08
city: Riga
country: Latvia
facility: Site Number - LAV01
city: Mexico City
country: Mexico
facility: Site Number - MEX01
state: Cdmx
city: Mexico City
country: Mexico
facility: Site Number - MEX02
state: Cdmx
city: Zwolle
country: Netherlands
facility: Site Number - NLD02
state: BV
city: Coimbra
country: Portugal
facility: Site Number - PRT02
city: Lisbon
country: Portugal
facility: Site Number - PRT03
city: Porto Covo
country: Portugal
facility: Site Number - PRT05
city: Belgrade
country: Serbia
facility: Site Number SRB 06
city: Belgrade
country: Serbia
facility: Site Number - SRB02
city: Kragujevac
country: Serbia
facility: Site Number - SRB03
city: Barcelona
country: Spain
facility: Site Number - ESP05
city: Barcelona
country: Spain
facility: Site Number - ESP12
city: Barcelona
country: Spain
facility: Site Number - ESP02
city: Madrid
country: Spain
facility: Site Number - ESP011
city: Madrid
country: Spain
facility: Site Number - ESP03
city: Málaga
country: Spain
facility: Site Number - ESP04
city: Málaga
country: Spain
facility: Site Number - ESP09
city: Pamplona
country: Spain
facility: Site Number - ESP06
city: Valencia
country: Spain
facility: Site Number - ESP08
city: Glasgow
country: United Kingdom
facility: Site Number - GBR04
city: London
country: United Kingdom
facility: Site Number - GBRXX
city: London
country: United Kingdom
facility: Site Number - GBR03
city: Newcastle Upon Tyne
country: United Kingdom
facility: Site Number - GBR05
city: Southampton
country: United Kingdom
facility: Site Number - GBR02
Study officials:
References: