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

NCT06719141 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: LP352-3012024-516412-17-00
• Study Type: interventional
• Target: 320
• Locations: 17 countries
• Sites: 109

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 (109)

Arkansas Children's Hospital - PIN

Little Rock, Arkansas, 72202, United States

RECRUITING

Children's Hospital Los Angeles - PIN

Los Angeles, California, 90027-6062, United States

RECRUITING

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-3075, United States

RECRUITING

The Stanford Division of Child Neurology

Palo Alto, California, 94304-1510, United States

RECRUITING

UCSF Children's Hospital

San Francisco, California, 94143-2350, United States

RECRUITING

Children's Hospital Colorado.

Aurora, Colorado, 80045-7106, United States

RECRUITING

Children's National Medical Center

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

RECRUITING

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561-4458, United States

RECRUITING

University of Miami - 1120 NW 14th St

Miami, Florida, 33136-2107, United States

RECRUITING

Nicklaus Children's Hospital - PIN

Miami, Florida, 33155-3009, United States

RECRUITING

Research Institute of Orlando LLC

Orlando, Florida, 32806-5411, United States

COMPLETED

University of South Florida - 2 Tampa General Circle

Tampa, Florida, 33606, United States

RECRUITING

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, 33609-4190, United States

RECRUITING

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

Atlanta, Georgia, 30329, United States

RECRUITING

Rare Disease Research, LLC - Atlanta - RDR - PIN

Atlanta, Georgia, 30329, United States

COMPLETED

Consultants In Epilepsy and Neurology PLLC

Boise, Idaho, 83702-5029, United States

RECRUITING

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Chicago, Illinois, 60611, United States

RECRUITING

University of Iowa Hospitals & Clinics - (CRS)

Iowa City, Iowa, 52242-1009, United States

RECRUITING

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817-1844, United States

RECRUITING

Massachusetts General Hospital - 175 Cambridge St

Boston, Massachusetts, 02114, United States

RECRUITING

Mayo Clinic - PIN

Rochester, Minnesota, 55905-0001, United States

RECRUITING

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, 07039-5817, United States

RECRUITING

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey, 07960, United States

RECRUITING

NYU Comprehensive Epilepsy Center - BRANY - PPDS

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

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239-3011, United States

RECRUITING

Le Bonheur Childrens Outpatient Center - PIN

Memphis, Tennessee, 38103-2816, United States

RECRUITING

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Austin, Texas, 78757, United States

RECRUITING

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

Fort Worth, Texas, 76104-2710, United States

RECRUITING

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

RECRUITING

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington, 98405-4048, United States

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane & Women's Hospital

Herston, Queensland, 4006, Australia

RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

Royal Children's Hospital Melbourne

Parkville, Victoria, 3052, Australia

RECRUITING

The Alfred Hospital

Melbourne, 3004, Australia

RECRUITING

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

UZ Leuven - PPDS

Leuven, 3000, Belgium

RECRUITING

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

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

Ribeirão Preto, São Paulo, 14051-140, Brazil

RECRUITING

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

RECRUITING

Instituto de Psiquiatria HC FMUSP

São Paulo, 05403-010, Brazil

RECRUITING

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

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, N6A 5W9, Canada

RECRUITING

Peking University First Hospital - Daxing Campus

Beijing, Beijing Municipality, 102627, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Wuhan Children's Hospital

Wuhan, Hubei, 430010, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, 100045, China

RECRUITING

Hôpital Roger Salengro

Lille, Nord, 59000, France

RECRUITING

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, 69500, France

RECRUITING

AP-HM- Hôpital de La Timone

Marseille, 13386, France

RECRUITING

Hôpital Necker - Enfants Malades

Paris, 75015, France

RECRUITING

AP-HP - Hôpital universitaire Robert-Debré

Paris, 75019, France

RECRUITING

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35203, France

RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31330, France

RECRUITING

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, 60596, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Epilepsiezentrum Kleinwachau gemeinnützige Gmbh

Radeberg, Saxony, 01454, Germany

RECRUITING

Gesellschaft für Epilepsieforschung e.V.

Bielefeld, 33617, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

RECRUITING

Epilepsie-Zentrum Bodensee

Ravensburg, 88214, Germany

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Roma, 00165, Holy See

RECRUITING

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, 00168, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, 50139, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, 37126, Italy

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genova, 16147, Italy

RECRUITING

IUHW Narita Hospital

Narita, Chiba, 286-8520, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaidô, 060-8648, Japan

RECRUITING

Fukuoka Children's Hospital

Fukuoka, Hukuoka, 813-0017, Japan

RECRUITING

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, 950-2074, Japan

RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

RECRUITING

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, 330-8777, Japan

RECRUITING

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, 420-0953, Japan

RECRUITING

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, 187-8502, Japan

RECRUITING

Dokkyo Medical University Hospital

Mibu-Machi, 321-0293, Japan

RECRUITING

Osaka City General Hospital

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

RECRUITING

Children's Clinical University Hospital

Riga, LV-1004, Latvia

RECRUITING

Universitair Medisch Centrum Utrecht - PPDS

Utrecht, 3584 CX, Netherlands

RECRUITING

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602, Portugal

RECRUITING

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

Lisbon, 1649-035, Portugal

RECRUITING

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto, 4050-651, Portugal

RECRUITING

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade, 11000, Serbia

RECRUITING

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, 11000, Serbia

RECRUITING

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, 190133, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Hospital Sant Joan de Deu - PIN

Espluges de Llobregat, Barcelona, 08950, Spain

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, 29010, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

RECRUITING

Hospital de La Santa Creu i Sant Pau

Barcelona, 8041, Spain

RECRUITING

Hospital Infantil Universitario Niño Jesus - PIN

Madrid, 28009, Spain

RECRUITING

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, 28010, Spain

RECRUITING

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, 28034, Spain

RECRUITING

Hospital Vithas Malaga

Málaga, 29016, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

RECRUITING

Queen Elizabeth University Hospital - PPDS

Glasgow, Glasgow City, G51 4TF, United Kingdom

RECRUITING

Royal Victoria Infirmary

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

RECRUITING

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

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

RECRUITING

University College London Hospitals (UCLH) - PPDS

London, NW1 2PG, United Kingdom

RECRUITING

Great Ormond Street Hospital - PPDS

London, WC1N 3JH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

RECRUITING

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

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

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: April 15, 2026

Record last verified: 2026-04

Locations

BE (2); ES (10); LA (1); IT (6); GB (7); NL (1); DE (6); US (30); CA (2); FR (8); SE (4); PT (3); BR (4); AU (8); CN (6); JP (10); HO (1)