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

NCT06719141 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: LP352-3012024-516412-17-00
• Study Type: interventional
• Target: 292
• Locations: 17 countries
• Sites: 116

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.

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

Outcome Measures

Primary Outcomes (1)

• Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline

  The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.

  Baseline and up to 15 Weeks

Secondary Outcomes (3)

• Safety and Tolerability of LP352

  Up to 21 Weeks

• Percentage of participants with ≥ 50% Reduction in countable motor seizures during the Treatment compared to Baseline

  Baseline and up to 15 Weeks

• Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline

  Baseline and up to 15 Weeks

Study Arms (2)

LP352

EXPERIMENTAL

Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.

Drug: LP352

Placebo

PLACEBO COMPARATOR

Placebo for LP352

Drug: Placebo

Interventions

LP352 DRUG

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

Also known as: Bexicaserin

LP352

Placebo DRUG

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

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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 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.

Sponsors & Collaborators

• Longboard Pharmaceuticals: lead

Study Sites (116)

Arkansas Children's Hospital - PIN

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Los Angeles - PIN

Los Angeles, California, 90027-6062, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-3075, United States

Location

The Stanford Division of Child Neurology

Palo Alto, California, 94304-1510, United States

Location

UCSF Children's Hospital

San Francisco, California, 94143-2350, United States

Location

Children's Hospital Colorado.

Aurora, Colorado, 80045-7106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2916, United States

Location

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561-4458, United States

Location

University of Miami - 1120 NW 14th St

Miami, Florida, 33136-2107, United States

Location

Nicklaus Children's Hospital - PIN

Miami, Florida, 33155-3009, United States

Location

Research Institute of Orlando LLC

Orlando, Florida, 32806-5411, United States

Location

University of South Florida - 2 Tampa General Circle

Tampa, Florida, 33606, United States

Location

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, 33609-4190, United States

Location

Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN

Atlanta, Georgia, 30329, United States

Location

Rare Disease Research, LLC - Atlanta - RDR - PIN

Atlanta, Georgia, 30329, United States

Location

Consultants In Epilepsy and Neurology PLLC

Boise, Idaho, 83702-5029, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611-5975, United States

Location

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals & Clinics - (CRS)

Iowa City, Iowa, 52242-1009, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817-1844, United States

Location

Massachusetts General Hospital - 175 Cambridge St

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic - PIN

Rochester, Minnesota, 55905-0001, United States

Location

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, 07039-5817, United States

Location

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey, 07960, United States

Location

NYU Comprehensive Epilepsy Center - BRANY - PPDS

New York, New York, 10016-4852, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3011, United States

Location

Le Bonheur Childrens Outpatient Center - PIN

Memphis, Tennessee, 38103-2816, United States

Location

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas, 78757, United States

Location

Cook Children's Jane and John Justin Neurosciences Center - PIN

Fort Worth, Texas, 76104-2710, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington, 98405-4048, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4006, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Royal Children's Hospital Melbourne

Parkville, Victoria, 3052, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

UZ Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

UZ Leuven - PPDS

Leuven, 3000, Belgium

Location

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, 81210-310, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Instituto do Cerebro do Rio Grande do Sul - InsCer

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto de Psiquiatria HC FMUSP

São Paulo, 05403-010, Brazil

Location

Children's and Women's Health Centre of British Columbia-4480 Oak St

Vancouver, British Columbia, V6H 3V4, Canada

Location

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, N6A 5W9, Canada

Location

Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality, 102627, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518000, China

Location

Wuhan Children's Hospital

Wuhan, Hubei, 430010, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, 100045, China

Location

Hôpital Roger Salengro

Lille, Nord, 59000, France

Location

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, 69500, France

Location

AP-HM- Hôpital de La Timone

Marseille, 13386, France

Location

Hôpital Necker - Enfants Malades

Paris, 75015, France

Location

AP-HP - Hôpital universitaire Robert-Debré

Paris, 75019, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35203, France

Location

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31330, France

Location

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, 60596, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Epilepsiezentrum Kleinwachau gemeinnützige Gmbh

Radeberg, Saxony, 01454, Germany

Location

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, 33617, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Epilepsie-Zentrum Bodensee

Ravensburg, 88214, Germany

Location

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

Location

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, 27100, Italy

Location

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, 50139, Italy

Location

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, 37126, Italy

Location

Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)

Genova, 16147, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

IUHW Narita Hospital

Narita, Chiba, 286-8520, Japan

Location

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaidô, 060-8648, Japan

Location

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, 950-2074, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka City General Hospital

Osaka-Shi Miyakojima-Ku, Osaka, 534-0021, Japan

Location

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, 330-8777, Japan

Location

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, 420-0953, Japan

Location

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, 187-8502, Japan

Location

Dokkyo Medical University Hospital

Mibu-Machi, 321-0293, Japan

Location

Children's Clinical University Hospital

Riga, Rīgas Apriņķis, LV-1004, Latvia

Location

Instituto Nacional de Pediatría

Mexico City, 4530, Mexico

Location

Universitair Medisch Centrum Utrecht - PPDS

Utrecht, 3584 CX, Netherlands

Location

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602, Portugal

Location

ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

Lisbon, 1649-035, Portugal

Location

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto, 4050-651, Portugal

Location

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade, 11000, Serbia

Location

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, 11000, Serbia

Location

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, 190133, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona, 08950, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Hospital Infantil Universitario Niño Jesus - PIN

Madrid, 28009, Spain

Location

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, 28010, Spain

Location

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, 28034, Spain

Location

Hospital Vithas Malaga

Málaga, 29016, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Royal Victoria Infirmary

Newcastle upon Tyne, Northamptonshire, NE1 4LP, United Kingdom

Location

Noah's Ark Children's Hospital for Wales - PIN

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Queen Elizabeth University Hospital - PPDS

Glasgow, G51 4TF, United Kingdom

Location

University College London Hospitals (UCLH) - PPDS

London, NW1 2PG, United Kingdom

Location

Great Ormond Street Hospital - PPDS

London, WC1N 3JH, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Lennox Gastaut Syndrome; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

BE (2); NL (1); FR (8); AU (8); JP (10); LA (1); DE (6); GB (7); ES (10); BR (7); SE (4); CA (4); PT (3); US (31); IT (7); CN (6); ME (1)