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)
Who is this study for? Patients with Dravet syndrome or Lennox-Gastaut syndrome
What treatments are being studied? Soticlestat
Status: Terminated
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 56
Healthy Volunteers: f
View:
⁃ 1\. Participant must have:
• Been previously enrolled in a phase 3 soticlestat clinical study.
Locations
United States
Arizona
Phoenix Childrens Hospital
Phoenix
Center For Neurosciences
Tucson
California
David Geffen School of Medicine at UCLA
Los Angeles
University of California Benioff Children's Hospital
San Francisco
Colorado
Colorado Children's Hospital
Denver
Florida
Pediatric Neurology PA
Winter Park
Georgia
Clinical Integrative Research Center of Atlanta
Atlanta
Sunrise Pediatric Neurology
Marietta
Iowa
University of Iowa Hospitals & Clinics - (CRS)
Iowa City
Maryland
Midatlantic Epilepsy and Sleep Center
Bethesda
Minnesota
Minnesota Epilepsy Group PA
Saint Paul
New Jersey
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston
New York
Boston Children's Health Physicians (BCHP)
New York
Northwell Health Physician Partners - Neurology at Lenox Hill
New York
NYU Comprehensive Epilepsy Center
New York
Ohio
University of Toledo
Toledo
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
St. Christopher's Hospital for Children
Philadelphia
Thomas Jefferson University
Philadelphia
WellSpan Oncology Research
York
South Carolina
Medical University of South Carolina Children Hospital - PIN
Charleston
Texas
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth
Utah
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City
Washington
Seattle Children's Hospital
Seattle
MultiCare Institute for Research & Innovation (Tacoma)
Tacoma
Other Locations
Australia
Queensland Childrens Hospital
Brisbane
Austin Hospital
Heidelberg
Alfred Hospital
Melbourne
Sydney Children's Hospital
Randwick
Belgium
Hopital Universitaire des Enfants Reine Fabiola
Brussels
UZ Antwerpen
Edegem
Centre Neurologique William Lennox
Ottignies-louvain-la-neuve
Brazil
Hospital das Clinicas - UNICAMP
Campinas
Instituto de Neurologia de Curitiba (INC)
Curitiba
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre
Universidade de Sao Paulo
São Paulo
Universidade Federal de Sao Paulo
São Paulo
Canada
Hospital For Sick Children
Toronto
Child and Family Research Institute
Vancouver
China
Beijing Children's Hospital,Capital Medical University
Beijing
Peking University First Hospital
Beijing
The First Hospital of Jilin University
Changchun
Xiangya Hospital of Central South University
Changsha
Children's Hospital of Chongqing Medical University
Chongqing
Guangzhou Women And Children's Medical Center
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical Univeristy
Guangzhou
Jiangxi Provincial Children's Hospital
Nanchang
Children's Hospital of Fudan University
Shanghai
Children's Hospital of Shanghai
Shanghai
Shenzhen Children's Hospital
Shenzhen
Wuhan Childrens hospital
Wuhan
France
CHRU Dijon Hopital General
Dijon
Hopital Roger Salengro
Lille
Hopitaux de La Timone
Marseille
Hopital Necker - Enfants Malades
Paris
Hopital Robert Debre
Paris
Germany
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt Am Main
Alberta Childrens Hospital
Freiburg Im Breisgau
Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
Radeberg
Greece
Childrens' Hospital of Athens 'P. and A. Kyriakou'
Athens
Attikon University General Hospital
Chaïdári
University General Hospital of Larissa
Larissa
Hippokration Hospital
Thessaloniki
Hungary
Bethesda Gyermekkorhaz
Budapest
Orszagos Klinikai Idegtudomanyi Intezet
Budapest
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest
Pecsi Tudomanyegyetem
Pécs
Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence
ASST di Mantova - Azienda Ospedaliera Carlo Poma
Mantova
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia
Fondazione Policlinico Universitario A Gemelli
Rome
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
Rome
Ospedale Bellaria
Rome
Japan
Hokkaido University Hospital
Chuo-ku
Fukuoka Children's Hospital
Fukuoka
National Center of Neurology and Psychiatry
Kodaira-shi
Kumamoto-Ezuko Medical Center for The Severely Disabled
Kumamoto
Aichi Medical University Hospital
Nagakute-shi
Yasuhara Childrens Clinic
Neyagawa
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata
Okayama University Hospital
Okayama
National Hospital Organization Nagasaki Medical Center
Omura-shi
Osaka City General Hospital
Osaka
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka
Osaka University Hospital
Suita-shi
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama
Latvia
Childrens University Hospital
Riga
Mexico
Hospital Civil Fray Antonio Alcalde
El Retiro
Netherlands
Kempenhaeghe - PPDS
Heeze
Stichting Epilepsie Instellingen Nederland
Zwolle
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Centrum Medyczne Plejady
Krakow
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw
Russian Federation
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk
Russian National Research Medical University n.a. N.I.Pirogov
Moscow
Russian National Research Medical University n.a. N.I.Pirogov
Moscow
Tyumen State Medical Academy
Tyumen
UGMK-Zdorojie, LLC
Yekaterinburg
Serbia
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade
University Clinical Center Nis
Niš
Children and Youth Health Care Institute of Vojvodina
Novi Sad
Spain
Hospital Regional Universitario de Malaga Hospital General
Almería
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
Hospital Vithas La Salud
Granada
Clinica Universidad Navarra
Pamplona
Centro de Neurologia Avanzada
Seville
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Ukraine
Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
Dnipro
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
Dnipro
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
Ivano-frankivsk
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
Kyiv
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Kyiv
Time Frame
Start Date: 2022-03-04
Completion Date: 2025-09-24
Participants
Target number of participants: 352
Treatments
Experimental: Soticlestat
Participants with DS and LGS will receive:Participants weighing \<45kg:Soticlestat,mini-tablets,titrated from lower dose level(60mg to 140mg) to higher dose(100mg to 200mg) twice daily(BID),based on body weight,orally/via enteral feeding tubes including but not limited to nasogastric(NG)-tube,gastrostomy tube(G-tube),MIC-KEY button,upto 2 weeks in Titration Period. Will continue to receive dose they are on at end of Titration Period,for approximately 4 years in Maintenance Period.Dose will be tapered down to lower dose(not less than lowest dose level based on weight)every 3 days until study drug is discontinued(upto 1week) in Taper Period.Participants weighing ≥45kg/adults:Soticlestat mini-tablets/tablets with starting dose of 200mg BID followed by 300mg BID,up to 2 weeks in Titration Period.Will continue to receive 300mg BID for approximately 4 years in Maintenance Period.Dose will be tapered down upto 100mg every 3 days until study drug is discontinued(up to 1 week) in Taper Period.
Authors
Alla Kyrychenko, Charuta Joshi, Joseph Sullivan, Jonathan Halford, Pavel Klein, Julio Flamini, Orrin Devinsky, Matthew Sweney, Michael Ciliberto, Todd Barron, Cecil Hahn, Angus Wilfong, Michael Sperling, Eric Marsh, Takateru Ishitsu, Stephane Auvin, Sylvie Nguyen, Russell Saneto, Rina Goldberg, Nitin Agarwal, Hisashi Kawawaki, Boudewijn Gunning, John Lawson, Katalin Hollody, Rocio Sanchez-Carpintero, Yucai Chen, Barbara Steinborn, Sergiusz Jozwiak, Katsuhiro Kobayashi, Pascal Vrielynck, Marian Majoie, Jianmin Zhong, Yuwu Jiang, Elena Belousova, Cyrus Boelman, Shin Nabatame, Jun Tohyama, Francesca Beccaria, Jing Peng, Jianxiang Liao, Shin Okazaki, Renzo Guerrini, Vicente Villanueva, Tokito Yamaguchi, Ryoko Honda, Diana Dmitrenko, Ryutaro Kira, Andras Fogarasi, Dimitrios Zafeiriou, Fang Fang, Terence OBrien, Akihisa Okumura, Alec Aeby, Ingrid Scheffer, Efthimios Dardiotis, Dan Sun, Wei-Ping Liao, Maria Mazurkiewicz-Beldzinska, Ruzica Kravljanac, Wen-Xiong Chen, Nikolay Zavadenko, Manuel Toledo, Eiji Nakagawa, Valentina De Giorgis, Daniel Fabo, Berten Ceulemans
Related Therapeutic Areas
Sponsors
Leads: Takeda