A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome

This (DEEp SEA 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 DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Study Overview

• Status: Recruiting
• Conditions: Dravet Syndrome
• Intervention / Treatment: Drug: LP352; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: HQ_Medinfo@Lundbeck.com

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • Recruiting
    • The Alfred Hospital
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Prince of Wales Hospital
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Sydney Children's Hospital
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Children's Hospital at Westmead
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Recruiting
      • Royal Brisbane & Women's Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Hospital
    • Parkville, Victoria, Australia, 3052
      • Recruiting
      • Royal Children's Hospital Melbourne
• Belgium
  • Antwerp, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
• Brazil
  • São Paulo, Brazil, 05403-010
    • Recruiting
    • Instituto de Psiquiatria HC FMUSP
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Recruiting
      • Instituto de Neurologia de Curitiba (INC)
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Recruiting
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Recruiting
      • Instituto do Cerebro do Rio Grande do Sul - InsCer
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-888
      • Recruiting
      • Hospital das Clinicas - UNICAMP
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Recruiting
      • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Recruiting
      • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Recruiting
      • Children's and Women's Health Centre of British Columbia-4480 Oak St
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre -800 Commissioners Rd E
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Hospital for Sick Children
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital
• China
  • Beijing, China, 100045
    • Recruiting
    • Beijing Children's Hospital, Capital Medical University - PIN
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102627
      • Recruiting
      • Peking University First Hospital - Daxing Campus
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen Children's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430010
      • Recruiting
      • Wuhan Children's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
• France
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon - Hôpital Pierre Wertheimer
  • Marseille, France, 13386
    • Recruiting
    • AP-HM- Hôpital de La Timone
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker - Enfants Malades
  • Paris, France, 75019
    • Recruiting
    • AP-HP - Hôpital universitaire Robert-Debré
  • Rennes, France, 35203
    • Recruiting
    • CHU de Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67098
    • Recruiting
    • CHU de Strasbourg - Hôpital de Hautepierre
  • Toulouse, France, 31330
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • Hôpital Roger Salengro
• Germany
  • Bielefeld, Germany, 33617
    • Recruiting
    • Gesellschaft für Epilepsieforschung e.V.
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein - Campus Kiel
  • Ravensburg, Germany, 88214
    • Recruiting
    • Epilepsie-Zentrum Bodensee
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60596
      • Recruiting
      • Klinikum der Johann-Wolfgang Goethe-Universitat
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Recruiting
      • Universitätsklinikum Bonn
• Italy
  • Genova, Italy, 16147
    • Recruiting
    • Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)
  • Roma, Italy, 00165
    • Recruiting
    • IRCCS Ospedale Pediatrico Bambino Gesu
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Recruiting
      • Azienda Ospedaliero Universitaria A Meyer (Duplicate)
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Recruiting
      • Azienda Ospedaliera Universitaria Integrata di Verona
• Japan
  • Chiba
    • Narita-shi, Chiba, Japan, 286-8520
      • Recruiting
      • IUHW Narita Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 813-0017
      • Recruiting
      • Fukuoka Children's Hospital
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 950-2074
      • Recruiting
      • National Hospital Organization Nishi-Niigata Chuo National Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Recruiting
      • Okayama University Hospital
  • Osaka
    • Osaka-Shi Miyakojima-Ku, Osaka, Japan, 534-0021
      • Recruiting
      • Osaka City General Hospital
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-8777
      • Recruiting
      • Saitama Prefectural Children's Medical Center
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 420-0953
      • Recruiting
      • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
  • Tochigi
    • Mibu-Machi, Tochigi, Japan, 321-0293
      • Recruiting
      • Dokkyo Medical University Hospital
  • Tokyo
    • Kodaira-Shi, Tokyo, Japan, 187-8502
      • Recruiting
      • National Center of Neurology and Psychiatry
• Latvia
  • Rīgas Apriņķis
    • Riga, Rīgas Apriņķis, Latvia, LV-1004
      • Recruiting
      • Children's Clinical University Hospital
• Mexico
  • Mexico City, Mexico, 4530
    • Recruiting
    • Instituto Nacional de Pediatría
• Portugal
  • Coimbra, Portugal, 3000-602
    • Recruiting
    • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
  • Lisbon, Portugal, 1649-035
    • Recruiting
    • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
  • Porto, Portugal, 4050-651
    • Recruiting
    • ULS de Santo António, EPE - Centro Materno Infantil Norte
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Clinic for Neurology and Psychiatry for Children and Youth
  • Belgrade, Serbia, 11000
    • Recruiting
    • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
  • Kragujevac, Serbia, 34000
    • Recruiting
    • University Clinical Center Kragujevac
  • Belgrade
    • Belgrade, Belgrade, Serbia, 11000
      • Recruiting
      • University Clinical Center of Serbia - Dr Subotica 6 - PPDS
• Spain
  • Barcelona, Spain, 8041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron - PPDS
  • Madrid, Spain, 28010
    • Recruiting
    • Hospital Universitario Vithas Madrid La Milagrosa
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ruber Internacional (Grupo Quironsalud)
  • Málaga, Spain, 29016
    • Recruiting
    • Hospital Vithas Malaga
  • Barcelona
    • Espluges de Llobregat, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Deu - PIN
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Recruiting
      • Hospital Regional Universitario de Malaga - Hospital General
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital - PPDS
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College London Hospitals (UCLH) - PPDS
  • London, United Kingdom, WC1N 3JH
    • Recruiting
    • Great Ormond Street Hospital - PPDS
  • Northamptonshire
    • Newcastle upon Tyne, Northamptonshire, United Kingdom, NE1 4LP
      • Recruiting
      • Royal Victoria Infirmary
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202-3500
      • Recruiting
      • Arkansas Children's Hospital - PIN
  • California
    • Los Angeles, California, United States, 90095-3075
      • Recruiting
      • David Geffen School of Medicine at UCLA
    • Los Angeles, California, United States, 90027-6062
      • Recruiting
      • Children's Hospital Los Angeles - PIN
    • Palo Alto, California, United States, 94304-1510
      • Recruiting
      • The Stanford Division of Child Neurology
    • San Francisco, California, United States, 94143-2350
      • Completed
      • UCSF Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045-7106
      • Recruiting
      • Children's Hospital Colorado.
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Children's National Medical Center
  • Florida
    • Gulf Breeze, Florida, United States, 32561-4458
      • Recruiting
      • NW FL Clinical Research Group, LLC
    • Miami, Florida, United States, 33155-3009
      • Recruiting
      • Nicklaus Children's Hospital - PIN
    • Orlando, Florida, United States, 32806-5411
      • Completed
      • Research Institute of Orlando LLC
    • Tampa, Florida, United States, 33609-4190
      • Recruiting
      • Pediatric Epilepsy and Neurology Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Completed
      • Rare Disease Research, LLC - Atlanta - RDR - PIN
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
  • Maryland
    • Bethesda, Maryland, United States, 20817-1844
      • Recruiting
      • Mid-Atlantic Epilepsy and Sleep Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic - PIN
  • New Jersey
    • Livingston, New Jersey, United States, 07039-5817
      • Recruiting
      • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
  • New York
    • New York, New York, United States, 10016-4852
      • Recruiting
      • NYU Comprehensive Epilepsy Center - BRANY - PPDS
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Recruiting
      • Oregon Health and Science University
  • Tennessee
    • Memphis, Tennessee, United States, 38103-2816
      • Recruiting
      • Le Bonheur Childrens Outpatient Center - PIN
  • Texas
    • Austin, Texas, United States, 78757
      • Recruiting
      • Child Neurology Consultants of Austin - 6811 Austin Center Blvd
    • Fort Worth, Texas, United States, 76104-2710
      • Recruiting
      • Cook Children's Jane and John Justin Neurosciences Center - PIN
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Medical School at Houston
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Multicare Health System - Mary Bridge Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of DS must fulfill all of the following criteria:

  1. Participants with seizure onset age >1 and <20 months
  2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
• 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 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.

Exclusion Criteria:

• The participant has a history of infantile/epileptic spasms.
• 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 unwilling to comply with any of the study requirements or timelines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for LP352	Drug: Placebo; Participants will be administered with matching placebo orally or through G-tube/ PEG tube; Other Names: Placebo Comparator
Experimental: 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.	Drug: LP352; LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube; Other Names: Bexicaserin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of LP352	Safety and tolerability as measured by incidence and severity of non-serious Treatment Emergent Adverse Events (TEAEs), Serious Adverse events (SAEs), AEs leading to discontinuation and clinically significant changes in laboratory parameters (hematology, serum chemistry and Urinalysis), physical examination findings, vital signs, growth parameters (height and weight), 12-lead electrocardiograms (ECGs), C-SSRS responses, and PHQ-9 total score and Question 9 score.	Up to 21 Weeks
Percentage of participants with ≥ 50% Reduction in countable motor seizures during 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

Collaborators and Investigators

• Sponsor: Longboard Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): October 2, 2026

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Epilepsy; Seizures; Antiseizure medication; Neurodevelopmental disorders; Developmental and epileptic encephalopathy; LP352; DEEp SEA; Bexicaserin
• Additional Relevant MeSH Terms: Epileptic Syndromes; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Epilepsy, Generalized; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurodevelopmental Disorders; Epilepsy; Seizures; Epilepsies, Myoclonic
• Other Study ID Numbers: LP352-302; 2024-514937-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No