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A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
Sponsor: Takeda
Summary
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.
Official title: 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 Young Adult Subjects With Dravet Syndrome (DS)
Key Details
Gender
All
Age Range
2 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2021-10-28
Completion Date
2024-04-11
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
Soticlestat
Soticlestat mini-tablets or tablets.
Placebo
Soticlestat placebo-matching mini-tablets or tablets.
Locations (66)
Phoenix Childrens Hospital
Phoenix, 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
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, United States
NYU Comprehensive Epilepsy Center
New York, New York, United States
University of Toledo
Toledo, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Seattle Children's Hospital
Seattle, Washington, United States
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, United States
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
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
Universidade de Sao Paulo
São Paulo, Brazil
Alberta Childrens Hospital
Calgary, Alberta, Canada
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 University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Wuhan Childrens hospital
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, 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, France
Hopital Necker - Enfants Malades
Paris, France
Hopital Robert Debre
Paris, France
Schon Klinik Vogtareuth
Vogtareuth, Bavaria, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, North Rhine-Westphalia, Germany
Attikon University General Hospital
Chaïdári, Attica, Greece
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
Budapest, Hungary
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
Rome, Lazio, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 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
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
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
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands
Stichting Epilepsie Instellingen Nederland
Zwolle, Overijssel, Netherlands
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland
Neurosphera SP. Z O.O
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
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
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Communal Non-profit Enterprise City Childrens Clinical Hospital #6 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