Clinical trial NCT06908226: A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
Official title: A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Developmental and Epileptic Encephalopathy
Keywords: Developmental and Epileptic Encephalopathy
LP352
Bexicaserin
Seizures
DEEp OLE
Antiseizure medications
Epilepsy
Neurodevelopmental disorders
Dravet syndrome
Lennox-gastaut syndrome
Lead sponsor: Longboard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-04-03
Enrollment: 324
Sex: ALL
Minimum age (years): 2
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.


Eligibility criteria: Inclusion Criteria:

* The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
* Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
* Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
* The participant or legal representative must be willing and able to provide written informed consent
* 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.

Exclusion Criteria:

* The participant is receiving exclusionary medications.
* Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥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: Number of participants reporting Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) and AEs leading to discontinuation
timeFrame: Up to 61 Weeks
measure: Number of Participants With Clinically Significant Changes in Chemistry parameters
timeFrame: Up to 61 Weeks
measure: Number of Participants With Clinically Significant Changes in Hematology parameters
timeFrame: Up to 61 Weeks
measure: Number of Participants With Clinically Significant Changes in Urinalysis
timeFrame: Up to 61 Weeks
measure: Number of participants with clinically significant changes in vital signs
timeFrame: Up to 61 Weeks
measure: Number of participants with clinically significant changes in physical examinations
timeFrame: Up to 61 Weeks
measure: Number of participants with clinically significant changes in growth parameters
timeFrame: Up to 61 Weeks
measure: Number of participants with clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 61 Weeks
measure: Number of participants with postive responses to Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 61 Weeks
measure: Number of participants with positive responses to Patient Health Questionnaire-9 (PHQ-9) and Question 9
timeFrame: Up to 61 Weeks
Secondary outcomes:
measure: Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
timeFrame: Baseline and up to 55 weeks
measure: Percentage of participants with ≥ 50% Reduction in countable motor seizures during Treatment compared to Baseline [Visit 1 of LP352-301 and LP352-302]
timeFrame: Baseline and up to 55 weeks
measure: Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline [Visit 1 of LP352-301 and LP352-302]
timeFrame: Baseline and up to 55 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: 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: 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: 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
Study officials:
References: