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

PHASE3CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

November 8, 2021

Primary Completion Date

January 25, 2024

Study Completion Date

January 25, 2024

Conditions
Lennox Gastaut Syndrome (LGS)
Interventions
DRUG

Placebo

Soticlestat placebo-matching mini-tablets or tablets.

DRUG

Soticlestat

Soticlestat mini-tablets or tablets.

Trial Locations (98)

168

Fondazione Policlinico Universitario A Gemelli, Rome

1023

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak, Budapest

1143

Bethesda Gyermekkorhaz, Budapest

1145

Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet, Budapest

1340

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

1454

Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh, Radeberg

2031

Sydney Children's Hospital, Randwick

2650

UZ Antwerpen PIN, 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, South 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

10001

Premier Healthcare Inc., New York

10016

NYU Comprehensive Epilepsy Center, New York

10075

Northwell Health Physician Partners - Neurology at Lenox Hill, 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

17403

WellSpan Oncology Research, York

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

29010

Hospital Regional Universitario de Malaga Hospital General, Málaga

29425

Medical University of South Carolina Children Hospital - PIN, Charleston

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

40139

Ospedale Bellaria, Bologna

41013

Centro de Neurologia Avanzada, Seville

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49100

Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC, Dnipro

49101

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

50139

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Florence

52242

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

55113

Minnesota Epilepsy Group PA, Roseville

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

80218

Children's Hospital Colorado., Denver

83569

Schon Klinik Vogtareuth, Vogtareuth

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

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 Central South University, Changsha

430010

Wuhan Childrens hospital, Wuhan

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

510623

Guangzhou Women And Children's Medical Center, Guangzhou

518026

Shenzhen Children's Hospital, Shenzhen

620144

UGMK-Zdorojie, LLC, Yekaterinburg

07039

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

Unknown

Hopital Universitaire des Enfants Reine Fabiola, Brussels

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

411 10

University General Hospital of Larissa, Larissa

546 42

Hippokration Hospital, Thessaloniki

480-1195

Aichi Medical University Hospital, Nagakute-Shi

813-0017

Fukuoka Children's Hospital, Fukuoka

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

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

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY