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TERMINATED
NCT05163314
PHASE3

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Official title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)

Key Details

Gender

All

Age Range

2 Years - 56 Years

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2022-03-04

Completion Date

2025-09-24

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

Soticlestat

Soticlestat mini-tablets or tablets

Locations (116)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Center For Neurosciences

Tucson, Arizona, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

University of California Benioff Children's Hospital

San Francisco, California, United States

Colorado Children's Hospital

Denver, Colorado, United States

Pediatric Neurology PA

Winter Park, Florida, United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States

Sunrise Pediatric Neurology

Marietta, Georgia, United States

University of Iowa Hospitals & Clinics - (CRS)

Iowa City, Iowa, United States

Midatlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Minnesota Epilepsy Group PA

Saint Paul, Minnesota, United States

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, United States

Boston Children's Health Physicians (BCHP)

New York, New York, United States

Northwell Health Physician Partners - Neurology at Lenox Hill

New York, New York, United States

NYU Comprehensive Epilepsy Center

New York, New York, United States

University of Toledo

Toledo, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

WellSpan Oncology Research

York, Pennsylvania, United States

Medical University of South Carolina Children Hospital - PIN

Charleston, South Carolina, United States

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

Fort Worth, Texas, United States

University of Utah - Primary Children's Hospital - PPDS

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

MultiCare Institute for Research & Innovation (Tacoma)

Tacoma, Washington, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

Queensland Childrens Hospital

Brisbane, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

UZ Antwerpen

Edegem, Antwerpen, Belgium

Centre Neurologique William Lennox

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

Hopital Universitaire des Enfants Reine Fabiola

Brussels, Brussels Capital, Belgium

Instituto de Neurologia de Curitiba (INC)

Curitiba, Paraná, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, Brazil

Universidade Federal de Sao Paulo

São Paulo, Brazil

Universidade de Sao Paulo

São Paulo, Brazil

Child and Family Research Institute

Vancouver, British Columbia, Canada

Hospital For Sick Children

Toronto, Ontario, Canada

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Children's Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical Univeristy

Guangzhou, Guangdong, China

Guangzhou Women And Children's Medical Center

Guangzhou, Guangdong, China

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

Wuhan Childrens hospital

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Hopitaux de La Timone

Marseille, Bouches-du-Rhone, France

CHRU Dijon Hopital General

Dijon, Cote-d'Or, France

Hopital Roger Salengro

Lille, Nord, France

Hopital Necker - Enfants Malades

Paris, France

Hopital Robert Debre

Paris, France

Alberta Childrens Hospital

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, Germany

Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

Bielefeld, North Rhine-Westphalia, Germany

Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

Radeberg, Saxony, Germany

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

Athens, Attica, Greece

Attikon University General Hospital

Chaïdári, Attica, Greece

University General Hospital of Larissa

Larissa, Greece

Hippokration Hospital

Thessaloniki, Greece

Pecsi Tudomanyegyetem

Pécs, Baranya, Hungary

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

Budapest, Hungary

Bethesda Gyermekkorhaz

Budapest, Hungary

Orszagos Klinikai Idegtudomanyi Intezet

Budapest, Hungary

Ospedale Bellaria

Rome, Lazio, Italy

IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

Rome, Lazio, Italy

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

ASST di Mantova - Azienda Ospedaliera Carlo Poma

Mantua, Lombardy, Italy

ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, Italy

Aichi Medical University Hospital

Nagakute-Shi, Aiti, Japan

Fukuoka Children's Hospital

Fukuoka, Hukuoka, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Kumamoto-Ezuko Medical Center for The Severely Disabled

Kumamoto, Kumamoto, Japan

National Hospital Organization Nagasaki Medical Center

Omura-Shi, Nagasaki, Japan

National Hospital Organization Nishi-Niigata Chuo National Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Yasuhara Childrens Clinic

Neyagawa, Osaka, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Suita-Shi, Osaka, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

Hokkaido University Hospital

Chuo-Ku, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, Japan

Childrens University Hospital

Riga, Latvia

Hospital Civil Fray Antonio Alcalde

El Retiro, Jalisco, Mexico

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands

Stichting Epilepsie Instellingen Nederland

Zwolle, Overijssel, Netherlands

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland

Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

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

Poznan, Poland

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

Moscow, Moscow, Russia

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

Krasnoyarsk, Russia

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

Moscow, Russia

Tyumen State Medical Academy

Tyumen, Russia

UGMK-Zdorojie, LLC

Yekaterinburg, Russia

Clinic for Neurology and Psychiatry for Children and Youth

Belgrade, Serbia

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, Serbia

University Clinical Center Nis

Niš, Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Hospital Regional Universitario de Malaga Hospital General

Almería, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Vithas La Salud

Granada, Spain

Centro de Neurologia Avanzada

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Ivano-Frankivsk, Ukraine

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

Kyiv, Ukraine

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

Kyiv, Ukraine