A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Description

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.

Conditions

Developmental and Epileptic Encephalopathy

Study Overview

Study Details

Study overview

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.

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

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Condition
Developmental and Epileptic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

Gulf Breeze

Site Number - USA02, Gulf Breeze, Florida, United States, 32561

Orlando

Site Number - USA05, Orlando, Florida, United States, 32806

Tampa

Site Number - USA11, Tampa, Florida, United States, 33609

Atlanta

Site Number - USA09, Atlanta, Georgia, United States, 30329

Bethesda

Site Number - USA07, Bethesda, Maryland, United States, 20817

Livingston

Site Number - USA10, Livingston, New Jersey, United States, 07039

Tacoma

Site Number - USA03, Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

2 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Longboard Pharmaceuticals,

Study Record Dates

2026-11