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

PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

April 11, 2024

Study Completion Date

April 11, 2024

Conditions
Dravet Syndrome (DS)
Interventions
DRUG

Soticlestat

Soticlestat mini-tablets or tablets.

DRUG

Placebo

Soticlestat placebo-matching mini-tablets or tablets.

Trial Locations (66)

164

IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN, Rome

168

Fondazione Policlinico Universitario A Gemelli, Rome

1145

Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet, Budapest

4080

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

4101

Queensland Childrens Hospital, South Brisbane

8035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

10016

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

13386

Hopitaux de La Timone, Marseille

27100

ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS, Pavia

29010

Hospital Regional Universitario de Malaga Hospital General, Málaga

29403

Medical University of South Carolina, Charleston

30328

Clinical Integrative Research Center of Atlanta, Atlanta

33617

Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel, Bielefeld

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49101

Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC, Dnipro

50139

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Florence

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

83569

Schon Klinik Vogtareuth, Vogtareuth

98405

Multicare Health System - Mary Bridge Pediatrics, 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

130021

The First Hospital of Jilin University, Changchun

200040

Children's Hospital of Shanghai, Shanghai

201102

Children's Hospital of Fudan University, Shanghai

400014

Children's Hospital of Chongqing Medical University, Chongqing

410008

Xiangya Hospital Central South University, Changsha

430010

Wuhan Childrens hospital, Wuhan

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

518026

Shenzhen Children's Hospital, Shenzhen

660022

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

85016-7710

Phoenix Childrens Hospital, Phoenix

90095-3075

David Geffen School of Medicine at UCLA, Los Angeles

94143-2350

University of California Benioff Children's Hospital, San Francisco

52242-1009

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

43606-3818

University of Toledo, Toledo

98105-3901

Seattle Children's Hospital, Seattle

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

04039-032

Universidade de Sao Paulo, São Paulo

T3B 6A8

Alberta Childrens Hospital, Calgary

V5Z 4H4

Child and Family Research Institute, Vancouver

M5G 1X8

Hospital For Sick Children, Toronto

124 62

Attikon University General Hospital, Chaïdári

480-1195

Aichi Medical University Hospital, Nagakute-Shi

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

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

02-952

Neurosphera SP. Z O.O, 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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY

NCT04940624 - A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome | Biotech Hunter | Biotech Hunter