A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
NCT ID: NCT06719141
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
320 participants
INTERVENTIONAL
2024-11-11
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LP352
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.
LP352
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
Placebo
Placebo for LP352
Placebo
Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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.
2 Years
65 Years
ALL
No
Sponsors
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Longboard Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Arkansas Children's Hospital - PIN
Little Rock, Arkansas, United States
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
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, Georgia, United States
Consultants In Epilepsy and Neurology PLLC
Boise, Idaho, 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
Oregon Health and Science University
Portland, Oregon, United States
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee, United States
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas, United States
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas, United States
The University of Texas Medical School at Houston
Houston, Texas, United States
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Sydney Children's Hospital
Randwick, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, Brazil
Instituto de Psiquiatria HC FMUSP
São Paulo, , Brazil
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada
Peking University First Hospital - Daxing Campus
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hôpital Roger Salengro
Lille, Nord, France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, , France
AP-HM- Hôpital de La Timone
Marseille, , France
AP-HP - Hôpital universitaire Robert-Debré
Paris, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Epilepsiezentrum Kleinwachau gemeinnützige Gmbh
Radeberg, Saxony, Germany
Gesellschaft für Epilepsieforschung e.V.
Bielefeld, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Epilepsie-Zentrum Bodensee
Ravensburg, , Germany
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genova, , Italy
Children's Clinical University Hospital
Riga, , Latvia
Universitair Medisch Centrum Utrecht - PPDS
Utrecht, , Netherlands
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, , Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, , Portugal
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade, Belgrade, Serbia
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, , Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, , Spain
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, , Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, , Spain
Hospital Vithas Malaga
Málaga, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Queen Elizabeth University Hospital - PPDS
Glasgow, Glasgow City, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Northamptonshire, United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-516412-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
LP352-301
Identifier Type: -
Identifier Source: org_study_id