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New drug LP352 aims to control seizures in severe epilepsy over the long term

NCT ID NCT06908226

Disease control Sponsor: Longboard Pharmaceuticals Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This phase 3 study is testing the long-term safety and effectiveness of LP352 (Bexicaserin) in 324 children and adults with developmental and epileptic encephalopathy (DEE), including Dravet and Lennox-Gastaut syndromes. Participants who completed earlier studies will receive LP352 orally or via feeding tube for about 14 months. The main goal is to track side effects, while also measuring changes in seizure frequency.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LP352 (Bexicaserin)
What this could lead to
If successful, this could provide a long-term treatment option to reduce seizure frequency in people with developmental and epileptic encephalopathy.
What could go wrong
This is an open-label study without a placebo, so results may be less reliable. Side effects and lack of efficacy are possible, and the study only includes people who completed earlier trials.

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

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

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 66 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: * The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration. * Diagnosis of DEE that includes Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302). * Participant has a body weight of ≥10 kg. * G-tubes/PEG tubes (if applicable) should be in stable and good working condition. Nasogastric tubes are not allowed except for short-term management. * Has at least one reliable and consistent parent, legal guardian, or caregiver during 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 LAR must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study. If the participant cannot provide consent or assent (ie, due to developmental status), the investigator should document why it was not obtained. * The participant and/or authorized representative is willing to provide written consent or assent to allow the investigator and the investigator's staff to consult with the participant's medical caregivers and the medical monitor during Screening and during participation in the study. * All participants of childbearing potential must have a negative urine or serum pregnancy (human chorionic gonadotropin) test at Visit 8 from Study LP352-301 or LP352-302 and agrees to routinely use an acceptable effective method of contraception from the time of signing informed consent up to 48 hours after the last dose of study drug. * Participant and/or participant's caregiver(s) agree to not post any participant's personal medical data related to the study or information related to the study on any website or social media site until the study has been completed. * 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. Exclusion Criteria: * The participant is receiving exclusionary medications. * Considered at risk of suicidal behavior based on the C-SSRS at Visit 8 of LP352-301 or LP352-302. If the participant is unable to complete the C-SSRS due to developmental status, the participant's LAR may not complete the C-SSRS. In these cases, the investigator may use clinical judgment to assess both the participant's status regarding suicidality and the ability to complete the scale, both of which must then be documented in the source document. * Has a PHQ-9 score of \>9 or a positive response to Question 9 at Visit 8 of LP352-301 or LP352-302. If the participant is unable to complete the PHQ-9, the participant's LAR may not complete the PHQ-9. In these cases, the investigator may use clinical judgment to assess both the participant's status and ability to complete the scale, both of which must then be documented in the source document. * Ongoing AE from LP352-301 or LP352-302 of severe depression, anorexia nervosa, or bulimia per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. * Has an abnormal and clinically significant 12-lead ECG at Visit 8 in LP352-301 or LP352-302 in the opinion of the investigator, for example, second- or third-degree heart block or a QTc of \>450 msec for adult males, \>470 msec for adult females, or \>440 msec for pediatric participants. * Ongoing AE in LP352-301 or LP352-302 of alcohol, opioid, or other drug use disorder, as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. * Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% THC. Cannabis product or cannabidiol should be used primarily to treat seizures and dose should not be adjusted for the duration of the study. Cannabis product or cannabidiol will count as a concurrent ASM. * Has a positive result on the urine drug screen at Visit 8 of LP352-301 or LP352-302, except for positive results related to prescribed controlled medications (eg, benzodiazepine) or Epidiolex®/government-approved cannabis product/cannabidiol used to treat seizures (eg, tetrahydrocannabinol). * 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 (severe hepatic impairment), renal (severe renal impairment), metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality at Visit 8 of LP352-301 or LP352-302 which may impact the ability of the participant to participate or potentially confound the study results. * Is pregnant, breast-feeding, or intending to become pregnant during or within 48 hours after the last dose of study drug; or intending to donate ova during such time period. * Has a known hypersensitivity to any component of LP352 formulation or any history of serious drug-induced hypersensitivity, eg, toxic epidermal necrolysis or Drug Reaction with Eosinophilia and Systemic Symptoms. * Unwilling to abstain from donation of blood during and within 2 weeks after the study. * Is unable or unwilling to comply with any of the study requirements or timelines.

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Conditions

The condition(s) this trial relates to.

developmental and epileptic encephalopathy Dravet syndrome Epilepsies, Myoclonic epilepsy Lennox-Gastaut syndrome neurodevelopmental disorder visual epilepsy

As listed by the trial registrant

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

Developmental and epileptic encephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

  • 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

  • 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

  • CHU de Toulouse - Hôpital Pierre-Paul Riquet

    Toulouse, 31059, France

  • Capital Medical University-Beijing Children's Hospital

    Beijing, Beijing Municipality, 100045, China

  • Cardiff and Vale University Health Board - University Hospital of Wales (UHW) - Noah's Ark Childr...

    Cardiff, East Wales, CF14 4XW, United Kingdom

  • 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

  • Consultants in Epilepsy & Neurology, PLLC

    Boise, Idaho, 83702-5029, United States

  • Dokkyo Medical University Hospital

    Mibu-Machi, Tochigi, 321-0293, Japan

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    Pavia, 27100, Italy

  • Fudan University - Children's Hospital

    Shanghai Shi, Shanghai Municipality, 201102, China

  • 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

  • Hospital Infantil Universitario Nino Jesus (HIUNJS)

    Madrid, 28009, Spain

  • 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 Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026, Spain

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid, 28010, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008, 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, Ain, 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

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114, United States

  • 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

  • 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

  • Northeast Regional Epilepsy Group - Morristown

    Morristown, New Jersey, 07960-6092, 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

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

    Brisbane, Queensland, 4101, Australia

  • 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

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

    Westmead, New South Wales, 2145, Australia

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

    São Paulo, 05403-903, 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 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

  • University of Miami Medical Group (UMMG)

    Miami, Florida, 33136-2117, United States

  • University of South Florida (USF) - Tampa Campus

    Tampa, Florida, 33620, United States

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Frankfurt - Klinikum der Goethe-Universität

    Frankfurt am Main, 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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