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Seizure drug safety trial halted early for dravet and LGS patients

NCT ID NCT05163314

Disease control Sponsor: Takeda 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of soticlestat when added to standard seizure medicines for people with Dravet syndrome or Lennox-Gastaut syndrome. It included 352 children and adults who had already been in earlier studies. The trial was terminated early, so results are limited.

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

352 people

The number who actually took part.

Started

Mar 2022

Finished

Sep 2025

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 56 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: 1\. Participant must have: * Been previously enrolled in a phase 3 soticlestat clinical study. Exclusion Criteria: 1. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted. 2. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) \>450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF. 3. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome

As listed by the trial registrant

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

Dravet syndrome (DS) Lennox-Gastaut syndrome (LGS)

Contacts and locations

Locations

  • ASST di Mantova - Azienda Ospedaliera Carlo Poma

    Mantua, Lombardy, 46100, Italy

  • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Aichi Medical University Hospital

    Nagakute-Shi, Aiti, 480-1195, Japan

  • Alberta Childrens Hospital

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Attikon University General Hospital

    Chaïdári, Attica, 124 62, Greece

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Florence, Tuscany, 50139, Italy

  • Beijing Children's Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • Bethesda Gyermekkorhaz

    Budapest, 1143, Hungary

  • Boston Children's Health Physicians (BCHP)

    New York, New York, 10003, United States

  • CHRU Dijon Hopital General

    Dijon, Cote-d'Or, 21079, France

  • CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

    Kyiv, 4080, Ukraine

  • Center For Neurosciences

    Tucson, Arizona, 85718, United States

  • Centre Neurologique William Lennox

    Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340, Belgium

  • Centro de Neurologia Avanzada

    Seville, 41013, Spain

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Child and Family Research Institute

    Vancouver, British Columbia, V5Z 4H4, Canada

  • Children and Youth Health Care Institute of Vojvodina

    Novi Sad, 21 000, Serbia

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014, China

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200040, China

  • Childrens University Hospital

    Riga, LV-1004, Latvia

  • Childrens' Hospital of Athens 'P. and A. Kyriakou'

    Athens, Attica, 115 27, Greece

  • Clinic for Neurology and Psychiatry for Children and Youth

    Belgrade, 11000, Serbia

  • Clinica Universidad Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinical Integrative Research Center of Atlanta

    Atlanta, Georgia, 30328, United States

  • Colorado Children's Hospital

    Denver, Colorado, 80218, United States

  • Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

    Ivano-Frankivsk, 76018, Ukraine

  • Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC

    Dnipro, Dnipropetrovsk Oblast, 49101, Ukraine

  • Cook Children's Medical Center - Jane and John Justin Neurosciences Center

    Fort Worth, Texas, 76104, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie

    Warsaw, Masovian Voivodeship, 02-091, Poland

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, Italy

  • Fukuoka Children's Hospital

    Fukuoka, Hukuoka, 813-0017, Japan

  • Guangzhou Women And Children's Medical Center

    Guangzhou, Guangdong, 510623, China

  • Hippokration Hospital

    Thessaloniki, 546 42, Greece

  • Hokkaido University Hospital

    Chuo-Ku, Tokyo, 104-0045, Japan

  • Hopital Necker - Enfants Malades

    Paris, 75015, France

  • Hopital Robert Debre

    Paris, 75019, France

  • Hopital Roger Salengro

    Lille, Nord, 59000, France

  • Hopital Universitaire des Enfants Reine Fabiola

    Brussels, Brussels Capital, 1020, Belgium

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhone, 13005, France

  • Hospital Civil Fray Antonio Alcalde

    El Retiro, Jalisco, 44280, Mexico

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital Regional Universitario de Malaga Hospital General

    Almería, 04009, Spain

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital Vithas La Salud

    Granada, 18008, Spain

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo, 13083-887, Brazil

  • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

    Rome, Lazio, 00197, Italy

  • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

    Livingston, New Jersey, 07039, United States

  • Instituto de Neurologia de Curitiba (INC)

    Curitiba, Paraná, 81210-310, Brazil

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, 330006, China

  • Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center

    Yokohama, Kanagawa, 232-0066, Japan

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE, Netherlands

  • Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

    Radeberg, Saxony, 01454, Germany

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse, 60528, Germany

  • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

    Krasnoyarsk, 660022, Russia

  • Kumamoto-Ezuko Medical Center for The Severely Disabled

    Kumamoto, Kumamoto, 862-0947, Japan

  • Medical University of South Carolina Children Hospital - PIN

    Charleston, South Carolina, 29425, United States

  • Midatlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817, United States

  • Minnesota Epilepsy Group PA

    Saint Paul, Minnesota, 55102, United States

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    Belgrade, 11000, Serbia

  • MultiCare Institute for Research & Innovation (Tacoma)

    Tacoma, Washington, 98402, United States

  • Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

    Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

  • NYU Comprehensive Epilepsy Center

    New York, New York, 10016, United States

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo, 187-0031, Japan

  • National Hospital Organization Nagasaki Medical Center

    Omura-Shi, Nagasaki, 856-0835, Japan

  • National Hospital Organization Nishi-Niigata Chuo National Hospital

    Niigata, Niigata, 950-2074, Japan

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, Shizuoka, 420-0953, Japan

  • Northwell Health Physician Partners - Neurology at Lenox Hill

    New York, New York, 10016, United States

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Orszagos Klinikai Idegtudomanyi Intezet

    Budapest, 1145, Hungary

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871, Japan

  • Ospedale Bellaria

    Rome, Lazio, 00185, Italy

  • Pecsi Tudomanyegyetem

    Pécs, Baranya, 7623, Hungary

  • Pediatric Neurology PA

    Winter Park, Florida, 32789, United States

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Queensland Childrens Hospital

    Brisbane, Queensland, 4101, Australia

  • Russian National Research Medical University n.a. N.I.Pirogov

    Moscow, Moscow, 117437, Russia

  • Russian National Research Medical University n.a. N.I.Pirogov

    Moscow, 125412, Russia

  • SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

    Kyiv, 4209, Ukraine

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518026, China

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134, United States

  • Stichting Epilepsie Instellingen Nederland

    Zwolle, Overijssel, 8025 BV, Netherlands

  • Sunrise Pediatric Neurology

    Marietta, Georgia, 30066, United States

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031, Australia

  • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

    Budapest, 1023, Hungary

  • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan, 60-355, Poland

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Guangzhou Medical Univeristy

    Guangzhou, Guangdong, 510260, China

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tyumen State Medical Academy

    Tyumen, 625023, Russia

  • UGMK-Zdorojie, LLC

    Yekaterinburg, 620144, Russia

  • UZ Antwerpen

    Edegem, Antwerpen, 2650, Belgium

  • Universidade Federal de Sao Paulo

    São Paulo, 04023-900, Brazil

  • Universidade de Sao Paulo

    São Paulo, 05403-010, Brazil

  • University Clinical Center Nis

    Niš, 18 000, Serbia

  • University General Hospital of Larissa

    Larissa, 411 10, Greece

  • University of California Benioff Children's Hospital

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals & Clinics - (CRS)

    Iowa City, Iowa, 52242, United States

  • University of Toledo

    Toledo, Ohio, 43614, United States

  • University of Utah - Primary Children's Hospital - PPDS

    Salt Lake City, Utah, 84113, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • WellSpan Oncology Research

    York, Pennsylvania, 17403, United States

  • Wuhan Childrens hospital

    Wuhan, Hubei, 430010, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Yasuhara Childrens Clinic

    Neyagawa, Osaka, 572-0085, Japan

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