Extended trial tests Add-On drug for severe childhood seizure disorders

NCT ID NCT05163314

Summary

This study aimed to check the long-term safety of an experimental drug called soticlestat when taken alongside standard medications. It involved about 352 children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome, two rare and severe forms of epilepsy. The main goal was to see if the drug was well-tolerated over several years while also measuring its effect on reducing seizure frequency.

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Contacts and locations

Locations

  • ASST di Mantova - Azienda Ospedaliera Carlo Poma

    Mantova, 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

Conditions

Explore the condition pages connected to this study.