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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Developmental and Epileptic Encephalopathy

In brief

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.

Key facts

Study ID: NCT06719141
Run by: Longboard Pharmaceuticals
People needed: 292
Starts: 2024-11-11
Expected to finish: 2026-11-30
Last updated by the study team: 2026-07-17

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Children's Hospital Los Angeles - PIN — Los Angeles, California, United States
David Geffen School of Medicine at UCLA — Los Angeles, California, United States
The Stanford Division of Child Neurology — Palo Alto, California, United States
UCSF Children's Hospital — San Francisco, California, United States
Children's Hospital Colorado. — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
University of Miami - 1120 NW 14th St — Miami, Florida, United States
Nicklaus Children's Hospital - PIN — Miami, Florida, United States
Research Institute of Orlando LLC — Orlando, Florida, United States
University of South Florida - 2 Tampa General Circle — Tampa, Florida, United States
Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN — Atlanta, Georgia, United States
Rare Disease Research, LLC - Atlanta - RDR - PIN — Atlanta, Georgia, United States
Consultants In Epilepsy and Neurology PLLC — Boise, Idaho, United States
Northwestern Memorial Hospital — Chicago, Illinois, United States
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN — Chicago, Illinois, United States
University of Iowa Hospitals & Clinics - (CRS) — Iowa City, Iowa, United States
Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
Massachusetts General Hospital - 175 Cambridge St — Boston, Massachusetts, United States
Mayo Clinic - PIN — Rochester, Minnesota, United States
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC — Livingston, New Jersey, United States
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave — Morristown, New Jersey, United States
NYU Comprehensive Epilepsy Center - BRANY - PPDS — New York, New York, United States
Arkansas Children's Hospital - PIN — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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