Clinical trial NCT06719141: A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
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 Developmental and Epileptic Encephalopathies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Developmental and Epileptic Encephalopathy
Keywords: Developmental and epileptic encephalopathy
LP352
Seizures
Bexicaserin
Antiseizure medications (ASMs)
Epilepsy
Lennox-Gastaut Syndrome (LGS)
Neurodevelopmental disorders
DEEp OCEAN
Lead sponsor: Longboard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 320
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 OCEAN 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 DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.


Eligibility criteria: Inclusion Criteria:

* Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill 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 seizure type(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 the following 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 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 each of 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; in instances where the participant is unable to provide consent, an appropriate legal representative.

Exclusion Criteria:

* The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.
* 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 of 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 unable or 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 the 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 - USA 08
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: Iowa City
country: United States
facility: Site Number - USA 13
state: Iowa
city: Bethesda
country: United States
facility: Site Number - USA07
state: Maryland
city: Boston
country: United States
facility: Site Number - USA30
state: Massachusetts
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 - AUS 09
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 - AUS 06
state: Victoria
city: Edegem
country: Belgium
facility: Site Number - BEL 01
city: Leuven
country: Belgium
facility: Site Number - BEL 02
city: Curitiba
country: Brazil
facility: Site Number - BRA 01
state: PR
city: Ribeirão Preto
country: Brazil
facility: Site Number - BRA 02
state: SP
city: São José Do Rio Preto
country: Brazil
facility: Site Number - BRA 05
state: SP
city: São Paulo
country: Brazil
facility: Site Number - BRA 03
state: SP
city: Vancouver
country: Canada
facility: Site Number - CAN 04
state: British Columbia
city: Toronto
country: Canada
facility: Site Number - CAN 01
state: Ontario
city: Toronto
country: Canada
facility: Site Number - CAN 03
state: Ontario
city: Beijing
country: China
facility: Site Number - CHN 01
city: Bron
country: France
facility: Site Number - FRA 08
city: Lille
country: France
facility: Site Number - FRA 04
city: Marseille
country: France
facility: Site Number - FRA 06
city: Paris
country: France
facility: Site Number - FRA 09
city: Paris
country: France
facility: Site Number - FRA 05
city: Rennes
country: France
facility: Site Number - FRA 01
city: Strasbourg
country: France
facility: Site Number - FRA 07
city: Toulouse
country: France
facility: Site Number - FRA 03
city: Bielefeld
country: Germany
facility: Site Number - DEU 02
city: Bonn
country: Germany
facility: Site Number - DEU 07
city: Frankfurt
country: Germany
facility: Site Number - DEU 01
city: Freiburg im Breisgau
country: Germany
facility: Site Number - DEU 04
city: Kiel
country: Germany
facility: Site Number - DEU 03
city: Radeberg
country: Germany
facility: Site Number - DEU 06
city: Ravensburg
country: Germany
facility: Site Number - DEU 05
city: Genova
country: Italy
facility: Site Number - ITA 03
city: Milan
country: Italy
facility: Site Number - ITA 07
city: Pavia
country: Italy
facility: Site Number - ITA 02
city: Roma
country: Italy
facility: Site Number - ITA 06
city: Roma
country: Italy
facility: Site Number - ITA 01
city: Toscana
country: Italy
facility: Site Number - ITA 04
city: Verona
country: Italy
facility: Site Number - ITA 08
city: Riga
country: Latvia
facility: Site Number - LVA 01
city: Mexico City
country: Mexico
facility: Site Number - MEX 01
state: Cdmx
city: Mexico City
country: Mexico
facility: Site Number - MEX 02
city: Zwolle
country: Netherlands
facility: Site Number - NLD 02
state: BV
city: Utrecht
country: Netherlands
facility: Site Number - NLD 03
state: CX
city: Coimbra
country: Portugal
facility: Site Number - PRT 02
city: Lisbon
country: Portugal
facility: Site Number - PRT 03
city: Porto Covo
country: Portugal
facility: Site Number - PRT 05
city: Belgrade
country: Serbia
facility: Site number - SRB 06
city: Belgrade
country: Serbia
facility: Site Number - SRB 02
city: Kragujevac
country: Serbia
facility: Site Number - SRB 03
city: Barcelona
country: Spain
facility: Site number - ESP 05
city: Barcelona
country: Spain
facility: Site number - ESP 12
city: Barcelona
country: Spain
facility: Site number - ESP 02
city: Madrid
country: Spain
facility: Site number - ESP 10
city: Madrid
country: Spain
facility: Site number - ESP 11
city: Madrid
country: Spain
facility: Site number - ESP 03
city: Málaga
country: Spain
facility: Site number - ESP 04
city: Málaga
country: Spain
facility: Site number - ESP 09
city: Pamplona
country: Spain
facility: Site number - ESP 06
city: Valencia
country: Spain
facility: Site number - ESP 08
city: Birmingham
country: United Kingdom
facility: Site number - GBR 01
city: Glasgow
country: United Kingdom
facility: Site number - GBR 04
city: London
country: United Kingdom
facility: Site number - GBRXX
city: London
country: United Kingdom
facility: Site number - GBR 03
city: Newcastle Upon Tyne
country: United Kingdom
facility: Site number - GBR 05
city: Southampton
country: United Kingdom
facility: Site number - GBR 02
Study officials:
References: