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A multicenter, randomized, Double-Blind, Placebo-Controlled, parallel group study to evaluate the efficacy, safety, and tolerability of soticlestat as adjunctive therapy in pediatric and adult subjects with Lennox-Gastaut syndrome (LGS)

NCT ID NCT04938427

NEW Sponsor: Takeda Source: ClinicalTrials.gov ↗

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

The aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.

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

270 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2024

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 55 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. Has documented clinical diagnosis of LGS. 2. Has had ≥8 MMD seizures each month in the 3 months prior to Screening based on the historical information and has had ≥8 MMD seizures per 28 days during the 4 to 6 week prospective Baseline Period. 3. Weighs ≥10 kg at the Screening Visit (Visit 1). 4. Failure to control seizures despite appropriate trials of at least 1 ASM based on historical information, and is currently on an antiseizure therapy or other treatment options considered as standard of care (SOC). 5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study. (Artisanal cannabidiols will not be counted as ASMs.) 6. Currently taking 0 to 3 ASMs at stable doses for at least 4 weeks before the Screening Visit (Visit 1); Fenfluramine and cannabidiol (Epidiolex) are allowed where available and counted as an ASM. ASM dosing regimen must remain constant throughout the study. Exclusion Criteria: 1. Admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately before Screening (Visit 1). For the purpose of this exclusion criterion, status is defined as continuous seizure activity lasting longer than 5 minutes or repeated seizures without return to Baseline in between seizures. 2. 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. 3. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 12 months before the Screening Visit (Visit 1). Participants who have positive answers on item numbers 4 or 5 on the Columbia suicide severity rating scale (C-SSRS) before dosing (Visit 2) 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.

Lennox-Gastaut syndrome

As listed by the trial registrant

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

Lennox Gastaut syndrome (LGS)

Contacts and locations

Locations

  • 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

    Calgary, Alberta, T3B 6A8, Canada

  • 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

  • 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 Colorado.

    Denver, Colorado, 80218, United States

  • 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

  • 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

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

    Ivano-Frankivsk, 76018, Ukraine

  • Communal Non-profit Enterprise City Childrens Clinical Hospital #6 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

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 168, 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

  • 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, Belgium

  • Hopitaux de La Timone

    Marseille, 13386, France

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital Regional Universitario de Malaga Hospital General

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

    Livingston, New Jersey, 07039, United States

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, 330006, China

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE, Netherlands

  • Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

    Radeberg, Sachse, 1454, Germany

  • Klinikum der Johann-Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse, 60528, Germany

  • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • 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

    Roseville, Minnesota, 55113, 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, 10075, United States

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

    Budapest, 1145, Hungary

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871, Japan

  • Ospedale Bellaria

    Bologna, Emilia-Romagna, 40139, 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

  • Premier Healthcare Inc.

    New York, New York, 10001, United States

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

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

    Kyiv, 4209, Ukraine

  • Schon Klinik Vogtareuth

    Vogtareuth, Bavaria, 83569, Germany

  • 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

  • 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 University

    Guangzhou, Guangdong, 510260, China

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UGMK-Zdorojie, LLC

    Yekaterinburg, 620144, Russia

  • UZ Antwerpen PIN

    Edegem, Antwerpen, 2650, Belgium

  • 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 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 Central South University

    Changsha, Hunan, 410008, China

  • Yasuhara Childrens Clinic

    Neyagawa, Osaka, 572-0085, Japan

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