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New hope for dravet syndrome: phase 3 trial of LP352 aims to cut seizure frequency

NCT ID NCT06660394

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests whether the drug LP352 can safely reduce seizures in children and adults with Dravet syndrome, a severe form of epilepsy. About 160 participants will receive either LP352 or a placebo, and researchers will track changes in seizure frequency over several months. The goal is to see if LP352 helps control seizures better than a dummy treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

96 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AP-HM- Hôpital de La Timone

    Marseille, 13005, France

  • AP-HP - Hôpital universitaire Necker-Enfants malades

    Paris, 75015, France

  • AP-HP - Hôpital universitaire Robert-Debré

    Paris, 75019, France

  • Aarhus Universitetshospital

    Aarhus, Central Jutland, 8200, Denmark

  • Arkansas Children's Hospital - Cardiology Clinic

    Little Rock, Arkansas, 72202-3500, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona)

    Verona, 37126, Italy

  • Azienda Ospedaliero-Universitaria Meyer - Ospedale dei Bambini

    Florence, Tuscany, 50139, Italy

  • BC Children's Hospital (British Columbia Children's Hospital)

    Vancouver, British Columbia, V6H 3V4, Canada

  • Barnabas Health - Institute of Neurology and Neurosurgery

    Livingston, New Jersey, 07039-5817, United States

  • Bernu Kliniska Universitates Slimnica (BKUS) (University Children's Hospital)

    Riga, LV-1004, Latvia

  • Capital Medical University-Beijing Children's Hospital

    Beijing, Beijing Municipality, 100045, China

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Psychiatrie

    Toulouse, Occitanie, 31059, France

  • Centre Hospitalier Universitaire de Lyon - Hôpital Pierre Wertheimer

    Bron, 69500, France

  • Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)

    Porto, 4050, Portugal

  • Child Neurology Consultants of Austin - Austin

    Austin, Texas, 78731-3157, United States

  • Children's Hospital Colorado - Heart Institute

    Aurora, Colorado, 80045-7106, United States

  • Children's Hospital Los Angeles (CHLA)

    Los Angeles, California, 90027-6062, United States

  • Children's National Hospital - Children's National Heart Center

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

  • Chu de Rennes - Centre d'Evaluation et de Traitement de la Douleur de l'Adulte et de l'Enfant

    Villejuif, Île-de-France Region, 94800, France

  • Clinical Center Kragujevac

    Kragujevac, Sumadijski Okrug, 34000, Serbia

  • Cook Children's Jane and John Justin Neurosciences Center

    Fort Worth, Texas, 76104-2710, United States

  • Dokkyo Medical University Hospital

    Mibu-Machi, Tochigi, 321-0293, Japan

  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214, Germany

  • Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP)

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

  • Filadelfia - Epilepsihospitalet (Danish Epilepsy Centre)

    Dianalund, Region Sjælland, 4293, Denmark

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    Pavia, 27100, Italy

  • Fudan University - Children's Hospital

    Shanghai Shi, Shanghai Municipality, 201102, China

  • Fukuoka Children's Hospital (FCH)

    Fukuoka, Fukuoka, 813-0017, Japan

  • Gesellschaft fuer Epilepsieforschung e.V.

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Guangzhou Medical University-The Second Affiliated Hospital

    Guangzhou, Guangdong, 510260, China

  • Helsingin Yliopistollinen Keskussairaala (HYKS) - Uusi Lastensairaala

    Helsinki, Uusimaa, 00029, Finland

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Pediátrico de Coimbra

    Coimbra, 3000-602, Portugal

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010, Spain

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Sant Joan de Deu Barcelona (HSJDB)

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid, 28010, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital Vithas Malaga

    Málaga, 29016, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 8041, Spain

  • Hôpital Roger Salengro

    Lille, Nord, 59000, France

  • Hôpital de Hautepierre - Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67098, France

  • Institut za Zdravstvenu Zastitu Majke i Deteta Srbije Dr Vukan Cupic

    Belgrade, Beograd, 11070, Serbia

  • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

    Mexico City, Mexico City, 04530, Mexico

  • Instituto de Neurologia de Curitiba (INC)

    Curitiba, Paraná, 81210-310, Brazil

  • International University of Health and Welfare - Narita Hospital

    Narita-shi, Chiba, 286-8520, Japan

  • Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare

    Genoa, 16147, Italy

  • Le Bonheur Children's Hospital - Outpatient Center

    Memphis, Tennessee, 38105-4625, United States

  • London Health Sciences Centre (LHSC)

    London, Ontario, N6A 5W9, Canada

  • Mayo Clinic - Children's Center - Rochester

    Rochester, Minnesota, 55905-0001, United States

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda, Maryland, 20817-1844, United States

  • Moinhos de Vento Hospital (Hospital Moinhos de Vento) (HMV)

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

  • MultiCare Health System

    Tacoma, Washington, 98415-0299, United States

  • NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...

    Glasgow, South Western Scotland, G51 4TF, United Kingdom

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561-4495, United States

  • NYU Langone Health-NYU Comprehensive Epilepsy Center

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

  • National Center of Neurology and Psychiatry-National Center Hospital

    Kodaira-shi, Tokyo-To, 187-8551, Japan

  • National Hospital Organization Nishi-Niigata Chuo National Hospital

    Niigata, 950-2074, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, 420-0953, Japan

  • Nicklaus Children's Hospital (Miami Children's Hospital)

    Miami, Florida, 33155-3009, United States

  • Northeast Regional Epilepsy Group - Morristown

    Morristown, New Jersey, 07960-6092, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611-2908, United States

  • Northwestern University - Ann & Robert H. Lurie Children's Hospital of Chicago - Center for Cance...

    Chicago, Illinois, 60611-2991, United States

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program

    Portland, Oregon, 97239-3098, United States

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Ospedale Pediatrico Bambino Gesu - Gianicolo

    Rome, 00165, Italy

  • Pediatric Epilepsy & Neurology Specialists (PENS)

    Tampa, Florida, 33609-4191, United States

  • Peking University First Hospital (Beida Hospital)

    Beijing, Beijing Municipality, 100034, China

  • Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Instituto Do Cerebro Do Rio Grand...

    Porto Alegre, Rio Grande do Sul, 90610-970, Brazil

  • Prince of Wales Hospital (POWH)

    Randwick, New South Wales, 2031, Australia

  • Queensland Children's Hospital (Lady Cilento Children's Hospital)

    Brisbane, Queensland, 4101, Australia

  • Rare Disease Research, LLC. (RDR)

    Atlanta, Georgia, 30329, United States

  • Research Institute of Orlando LLC

    Orlando, Florida, 32806, United States

  • Royal Brisbane and Women's Hospital (RBWH)

    Brisbane, Queensland, 4006, Australia

  • Saitama Prefectural Children's Medical Center

    Saitama-shi, Saitama, 330-8777, Japan

  • Shenzhen Children's Hospital

    Shenzhen Shi, Guangdong, 518026, China

  • Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center

    Palo Alto, California, 94304-1511, United States

  • Sydney Children's Hospital - Randwick

    Randwick, New South Wales, 2031, Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Children's Hospital-Westmead - Heart Centre for Children

    Westmead, New South Wales, 2145, Australia

  • The Hospital for Sick Children (SickKids)

    Toronto, Ontario, M5G 1X8, Canada

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)

    Newcastle upon Tyne, North East, NE1 4LP, United Kingdom

  • The Royal Children's Hospital (RCH) Melbourne

    Parkville, Victoria, 3052, Australia

  • The University of Texas Medical School at Houston - UT Gastroenterology

    Houston, Texas, 77030-1517, United States

  • UCSF Benioff Children's Hospitals - San Francisco

    San Francisco, California, 94158, United States

  • Unidade Local de Saude Santa Maria, E.P.E (ULSSM)

    Lisbon, 1649-035, Portugal

  • Universidade Estadual de Campinas (UNICAMP) - Hospital das Clinicas (HC)

    Campinas, São Paulo, 13083-888, Brazil

  • Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) - Inst...

    São Paulo, 05403-903, Brazil

  • Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto ...

    Ribeirão Preto, São Paulo, 14051-260, Brazil

  • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario A Gemelli - Centro pe...

    Rome, 00168, Italy

  • Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Kiel - Klinik fuer Psychosomatik und Psy...

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, Antwerp, 2650, Belgium

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • University College London Hospitals NHS Foundation Trust (UCLH)

    London, NW1 2PG, United Kingdom

  • University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC)

    Toronto, Ontario, M5T 2S8, Canada

  • University of Belgrade-Faculty of Medicine - Clinic of Neurology and Psychiatry for Children and ...

    Belgrade, Beograd, 112112, Serbia

  • University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro...

    Los Angeles, California, 90095, United States

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Frankfurt - Klinikum der Goethe-Universität

    Frankfurt am Main, Hesse, 60596, Germany

  • Univerzitetski Klinicki Centar Srbije - Klinika za Neurologiju

    Belgrade, Beograd, 11000, Serbia

  • Wuhan Children's Hospital

    Wuhan, Hubei, 430016, China

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