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Clinical Trials in the USA / NCT06719141
Active, not recruiting Phase 3

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

NCT06719141 · tracked via the Priya Life Science USA tracker
Sponsor
Longboard Pharmaceuticals
Phase
Phase 3
Started
2024-11-11
Last updated
2026-09-15

Condition(s) studied

Developmental and Epileptic Encephalopathy

Investigational drug(s) / intervention(s)

LP352Placebo

LP352: LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube

Placebo: Participants will be administered with matching placebo orally or through G-tube/ PEG tube.

Study 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

Sex
ALL
Min age
2 Years
Max age
65 Years
Healthy volunteers
No
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 is currently using 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 outcome measure(s)

Trial sites (116)

FacilityCityRegionStatus
Arkansas Children's Hospital - Cardiology Clinic Little Rock Arkansas
Children's Hospital Los Angeles (CHLA) Los Angeles California
University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro... Los Angeles California
Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center Palo Alto California
UCSF Benioff Children's Hospitals - San Francisco San Francisco California
Children's Hospital Colorado - Heart Institute Aurora Colorado
Children's National Hospital - Children's National Heart Center Washington D.C. District of Columbia
NW FL Clinical Research Group, LLC Gulf Breeze Florida
University of Miami Medical Group (UMMG) Miami Florida
Nicklaus Children's Hospital (Miami Children's Hospital) Miami Florida
Research Institute of Orlando LLC Orlando Florida
Pediatric Epilepsy & Neurology Specialists (PENS) Tampa Florida
University of South Florida (USF) - Tampa Campus Tampa Florida
Children's Healthcare of Atlanta (CHOA) Atlanta Georgia
Rare Disease Research, LLC. (RDR) Atlanta Georgia
Consultants in Epilepsy & Neurology, PLLC Boise Idaho
Northwestern Memorial Hospital Chicago Illinois
Northwestern University - Ann & Robert H. Lurie Children's Hospital of Chicago - Center for Cance... Chicago Illinois
University of Iowa Health Care Medical Center (University of Iowa Hospitals & Clinics) Iowa City Iowa
Mid-Atlantic Epilepsy and Sleep Center - Bethesda Bethesda Maryland
Massachusetts General Hospital (MGH) Boston Massachusetts
Mayo Clinic - Children's Center - Rochester Rochester Minnesota
Barnabas Health - Institute of Neurology and Neurosurgery Livingston New Jersey
Northeast Regional Epilepsy Group - Morristown Morristown New Jersey
NYU Langone Health-NYU Comprehensive Epilepsy Center New York New York
Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program Portland Oregon
Le Bonheur Children's Hospital - Outpatient Center Memphis Tennessee
Child Neurology Consultants of Austin - Austin Austin Texas
Cook Children's Jane and John Justin Neurosciences Center Fort Worth Texas
The University of Texas Medical School at Houston - UT Gastroenterology Houston Texas
MultiCare Health System Tacoma Washington
Prince of Wales Hospital (POWH) Randwick New South Wales
Sydney Children's Hospital - Randwick Randwick New South Wales
The Children's Hospital-Westmead - Heart Centre for Children Westmead New South Wales
Royal Brisbane and Women's Hospital (RBWH) Brisbane Queensland
Queensland Children's Hospital (Lady Cilento Children's Hospital) Brisbane Queensland
Austin Hospital Heidelberg Victoria
The Alfred Hospital Melbourne Victoria
The Royal Children's Hospital (RCH) Melbourne Parkville Victoria
Universitair Ziekenhuis Antwerpen (UZA) Edegem Antwerp

+ 76 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06719141 on ClinicalTrials.gov ↗ ← All trials in the USA