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

PHASE3TerminatedINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

March 4, 2022

Primary Completion Date

September 24, 2025

Study Completion Date

September 24, 2025

Conditions
Dravet Syndrome (DS)Lennox Gastaut Syndrome (LGS)
Interventions
DRUG

Soticlestat

Soticlestat mini-tablets or tablets

Trial Locations (116)

1020

Hopital Universitaire des Enfants Reine Fabiola, Brussels

1023

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak, Budapest

1143

Bethesda Gyermekkorhaz, Budapest

1145

Orszagos Klinikai Idegtudomanyi Intezet, Budapest

1340

Centre Neurologique William Lennox, Ottignies-Louvain-la-Neuve

2031

Sydney Children's Hospital, Randwick

2650

UZ Antwerpen, Edegem

3004

Alfred Hospital, Melbourne

3084

Austin Hospital, Heidelberg

4080

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

4101

Queensland Childrens Hospital, Brisbane

4209

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

7623

Pecsi Tudomanyegyetem, Pécs

8035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

10003

Boston Children's Health Physicians (BCHP), New York

10016

Northwell Health Physician Partners - Neurology at Lenox Hill, New York

NYU Comprehensive Epilepsy Center, New York

11000

Clinic for Neurology and Psychiatry for Children and Youth, Belgrade

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic, Belgrade

13005

Hopitaux de La Timone, Marseille

17403

WellSpan Oncology Research, York

18008

Hospital Vithas La Salud, Granada

19104

Children's Hospital of Philadelphia, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19134

St. Christopher's Hospital for Children, Philadelphia

20817

Midatlantic Epilepsy and Sleep Center, Bethesda

21079

CHRU Dijon Hopital General, Dijon

27100

ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS, Pavia

29425

Medical University of South Carolina Children Hospital - PIN, Charleston

30066

Sunrise Pediatric Neurology, Marietta

30328

Clinical Integrative Research Center of Atlanta, Atlanta

31008

Clinica Universidad Navarra, Pamplona

32789

Pediatric Neurology PA, Winter Park

33617

Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel, Bielefeld

41013

Centro de Neurologia Avanzada, Seville

43614

University of Toledo, Toledo

44280

Hospital Civil Fray Antonio Alcalde, El Retiro

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

46100

ASST di Mantova - Azienda Ospedaliera Carlo Poma, Mantova

49100

Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC, Dnipro

49101

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

50139

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Florence

52242

University of Iowa Hospitals & Clinics - (CRS), Iowa City

55102

Minnesota Epilepsy Group PA, Saint Paul

59000

Hopital Roger Salengro, Lille

60528

Klinikum der Johann-Wolfgang Goethe-Universitat, Frankfurt am Main

75015

Hopital Necker - Enfants Malades, Paris

75019

Hopital Robert Debre, Paris

76018

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

76104

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

79106

Alberta Childrens Hospital, Freiburg im Breisgau

80218

Colorado Children's Hospital, Denver

84113

University of Utah - Primary Children's Hospital - PPDS, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

85718

Center For Neurosciences, Tucson

90095

David Geffen School of Medicine at UCLA, Los Angeles

94143

University of California Benioff Children's Hospital, San Francisco

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

98402

MultiCare Institute for Research & Innovation (Tacoma), Tacoma

100034

Peking University First Hospital, Beijing

100045

Beijing Children's Hospital,Capital Medical University, Beijing

117437

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

125412

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

130021

The First Hospital of Jilin University, Changchun

200040

Children's Hospital of Shanghai, Shanghai

201102

Children's Hospital of Fudan University, Shanghai

330006

Jiangxi Provincial Children's Hospital, Nanchang

400014

Children's Hospital of Chongqing Medical University, Chongqing

410008

Xiangya Hospital of Central South University, Changsha

430010

Wuhan Childrens hospital, Wuhan

510260

The Second Affiliated Hospital of Guangzhou Medical Univeristy, Guangzhou

510623

Guangzhou Women And Children's Medical Center, Guangzhou

518026

Shenzhen Children's Hospital, Shenzhen

620144

UGMK-Zdorojie, LLC, Yekaterinburg

625023

Tyumen State Medical Academy, Tyumen

660022

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

07039

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC, Livingston

81210-310

Instituto de Neurologia de Curitiba (INC), Curitiba

90610-000

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

13083-887

Hospital das Clinicas - UNICAMP, Campinas

04023-900

Universidade Federal de Sao Paulo, São Paulo

05403-010

Universidade de Sao Paulo, São Paulo

V5Z 4H4

Child and Family Research Institute, Vancouver

M5G 1X8

Hospital For Sick Children, Toronto

01454

Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh, Radeberg

115 27

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

124 62

Attikon University General Hospital, Chaïdári

411 10

University General Hospital of Larissa, Larissa

546 42

Hippokration Hospital, Thessaloniki

00185

Ospedale Bellaria, Rome

00197

IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN, Rome

Unknown

Fondazione Policlinico Universitario A Gemelli, Rome

480-1195

Aichi Medical University Hospital, Nagakute-Shi

813-0017

Fukuoka Children's Hospital, Fukuoka

232-0066

Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center, Yokohama

862-0947

Kumamoto-Ezuko Medical Center for The Severely Disabled, Kumamoto

856-0835

National Hospital Organization Nagasaki Medical Center, Omura-Shi

950-2074

National Hospital Organization Nishi-Niigata Chuo National Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

572-0085

Yasuhara Childrens Clinic, Neyagawa

534-0021

Osaka City General Hospital, Osaka

565-0871

Osaka University Hospital, Suita-Shi

420-0953

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka

104-0045

Hokkaido University Hospital, Chuo-Ku

187-0031

National Center of Neurology and Psychiatry, Kodaira-Shi

LV-1004

Childrens University Hospital, Riga

5591 VE

Kempenhaeghe - PPDS, Heeze

8025 BV

Stichting Epilepsie Instellingen Nederland, Zwolle

30-363

Centrum Medyczne Plejady, Krakow

02-091

Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie, Warsaw

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

60-355

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

18 000

University Clinical Center Nis, Niš

21 000

Children and Youth Health Care Institute of Vojvodina, Novi Sad

04009

Hospital Regional Universitario de Malaga Hospital General, Almería

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY

NCT05163314 - A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Biotech Hunter | Biotech Hunter