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
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Locations
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ASST di Mantova - Azienda Ospedaliera Carlo Poma
Mantova, Lombardy, 46100, Italy
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ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, 27100, Italy
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Aichi Medical University Hospital
Nagakute-Shi, Aiti, 480-1195, Japan
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Alberta Childrens Hospital
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Alfred Hospital
Melbourne, Victoria, 3004, Australia
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Attikon University General Hospital
Chaïdári, Attica, 124 62, Greece
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Austin Hospital
Heidelberg, Victoria, 3084, Australia
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Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, 50139, Italy
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Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, 100045, China
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Bethesda Gyermekkorhaz
Budapest, 1143, Hungary
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Boston Children's Health Physicians (BCHP)
New York, New York, 10003, United States
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CHRU Dijon Hopital General
Dijon, Cote-d'Or, 21079, France
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CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
Kyiv, 4080, Ukraine
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Center For Neurosciences
Tucson, Arizona, 85718, United States
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Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340, Belgium
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Centro de Neurologia Avanzada
Seville, 41013, Spain
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Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363, Poland
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Child and Family Research Institute
Vancouver, British Columbia, V5Z 4H4, Canada
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Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21 000, Serbia
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040, China
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Childrens University Hospital
Riga, LV-1004, Latvia
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Childrens' Hospital of Athens 'P. and A. Kyriakou'
Athens, Attica, 115 27, Greece
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Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, 11000, Serbia
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Clinica Universidad Navarra
Pamplona, Navarre, 31008, Spain
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Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328, United States
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Colorado Children's Hospital
Denver, Colorado, 80218, United States
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Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
Ivano-Frankivsk, 76018, Ukraine
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Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
Dnipro, Dnipropetrovsk Oblast, 49101, Ukraine
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Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, 76104, United States
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David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
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Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, Masovian Voivodeship, 02-091, Poland
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Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
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Fukuoka Children's Hospital
Fukuoka, Hukuoka, 813-0017, Japan
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Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, 510623, China
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Hippokration Hospital
Thessaloniki, 546 42, Greece
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Hokkaido University Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
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Hopital Necker - Enfants Malades
Paris, 75015, France
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Hopital Robert Debre
Paris, 75019, France
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Hopital Roger Salengro
Lille, Nord, 59000, France
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Hopital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, 1020, Belgium
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Hopitaux de La Timone
Marseille, Bouches-du-Rhone, 13005, France
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Hospital Civil Fray Antonio Alcalde
El Retiro, Jalisco, 44280, Mexico
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Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
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Hospital Regional Universitario de Malaga Hospital General
Almería, 04009, Spain
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Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
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Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
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Hospital Vithas La Salud
Granada, 18008, Spain
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Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-887, Brazil
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IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
Rome, Lazio, 00197, Italy
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Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, 07039, United States
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Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, 81210-310, Brazil
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Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006, China
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Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama, Kanagawa, 232-0066, Japan
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Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE, Netherlands
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Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
Radeberg, Saxony, 01454, Germany
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Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, 60528, Germany
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Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, North Rhine-Westphalia, 33617, Germany
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Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk, 660022, Russia
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Kumamoto-Ezuko Medical Center for The Severely Disabled
Kumamoto, Kumamoto, 862-0947, Japan
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Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, 29425, United States
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Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
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Minnesota Epilepsy Group PA
Saint Paul, Minnesota, 55102, United States
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Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, 11000, Serbia
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MultiCare Institute for Research & Innovation (Tacoma)
Tacoma, Washington, 98402, United States
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Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine
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NYU Comprehensive Epilepsy Center
New York, New York, 10016, United States
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National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, 187-0031, Japan
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National Hospital Organization Nagasaki Medical Center
Omura-Shi, Nagasaki, 856-0835, Japan
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National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, 950-2074, Japan
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National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-0953, Japan
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Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, 10016, United States
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Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Orszagos Klinikai Idegtudomanyi Intezet
Budapest, 1145, Hungary
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Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
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Osaka University Hospital
Suita-Shi, Osaka, 565-0871, Japan
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Ospedale Bellaria
Rome, Lazio, 00185, Italy
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Pecsi Tudomanyegyetem
Pécs, Baranya, 7623, Hungary
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Pediatric Neurology PA
Winter Park, Florida, 32789, United States
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
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Queensland Childrens Hospital
Brisbane, Queensland, 4101, Australia
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Russian National Research Medical University n.a. N.I.Pirogov
Moscow, Moscow, 117437, Russia
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Russian National Research Medical University n.a. N.I.Pirogov
Moscow, 125412, Russia
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SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Kyiv, 4209, Ukraine
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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Shenzhen Children's Hospital
Shenzhen, Guangdong, 518026, China
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St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
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Stichting Epilepsie Instellingen Nederland
Zwolle, Overijssel, 8025 BV, Netherlands
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Sunrise Pediatric Neurology
Marietta, Georgia, 30066, United States
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Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
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Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, 1023, Hungary
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Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355, Poland
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The First Hospital of Jilin University
Changchun, Jilin, 130021, China
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The Second Affiliated Hospital of Guangzhou Medical Univeristy
Guangzhou, Guangdong, 510260, China
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Tyumen State Medical Academy
Tyumen, 625023, Russia
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UGMK-Zdorojie, LLC
Yekaterinburg, 620144, Russia
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UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
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Universidade Federal de Sao Paulo
São Paulo, 04023-900, Brazil
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Universidade de Sao Paulo
São Paulo, 05403-010, Brazil
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University Clinical Center Nis
Niš, 18 000, Serbia
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University General Hospital of Larissa
Larissa, 411 10, Greece
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University of California Benioff Children's Hospital
San Francisco, California, 94143, United States
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University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, 52242, United States
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University of Toledo
Toledo, Ohio, 43614, United States
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University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah, 84113, United States
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Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
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WellSpan Oncology Research
York, Pennsylvania, 17403, United States
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Wuhan Childrens hospital
Wuhan, Hubei, 430010, China
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Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
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Yasuhara Childrens Clinic
Neyagawa, Osaka, 572-0085, Japan
Conditions
Explore the condition pages connected to this study.