Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

September 9, 2024

Study Completion Date

October 14, 2024

Conditions
Tuberous Sclerosis Complex
Interventions
DRUG

Ganaxolone

GNX will be administered

DRUG

Placebo

Placebo will be administered

Trial Locations (63)

3004

Alfred Health, Melbourne

3050

Royal Melbourne Hospital, Parkville

3084

Austin Health, Heidelberg

4029

Royal Brisbane and Women's Hospital, Herston

14642

University of Rochester Medical Center, Rochester

16147

Pediatric Neurology and Muscular Diseases Unit - University of Genoa, Genova

17033

Penn State Children's Hospital, Hershey

19803

Nemours Children's Hospital - Delaware Valley, Wilmington

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

27599

University of North Carolina at Chapel Hill, Chapel Hill

27712

Duke University Medical Center, Durham

28009

Hospital Infantil Universitario Niño Jesús, Madrid

28034

Hospital Ruber International, Madrid

28207

Atrium Health/Levine Children's Hospital, Charlotte

29010

Hospital Regional Universitario de Málaga, Málaga

32207

Nemours Children's Health, Jacksonville

32608

University of Florida Gainesville, Gainesville

33617

Epilepsie-Zentrum Bethel - Krankenhaus Mara, Bielefeld

35033

University Hospital of Rennes, Rennes

38103

Le Bonheur Children's Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46026

Hospital Universitario y Politécnico La Fe, Valencia

52621

Sheba Medical Center, Tel Litwinsky

53127

University Hospital Bonn, Bonn

55905

Mayo Clinic - Rochester, Rochester

58313

Gemeinschaftskrankenhaus Herdecke, Herdecke

60528

ZNN - Epilepsiezentrum Frankfurt am Main, Frankfurt

64108

Children's Mercy Hosptial, Kansas City

67084

University of Strasbourg, Strasbourg

69229

University Hospital of Lyon, Bron

72202

Arkansas Children's Research Institute, Little Rock

75207

University of Texas Southwestern Medical Center, Dallas

77030

McGovern Medical School at the University of Texas Health Science Center, Houston

78757

Child Neurology Consultants of Austin (CNCA), Austin

79106

Universitäts Krankenhaus Freiburg, Freiburg im Breisgau

80045

Childrens Hospital Colorado, Aurora

84108

University of Utah Health Care-Pediatric Neurology, Salt Lake City

90095

UCLA Mattel Children's Hospital, TSC Center, Los Angeles

92123

University of California, San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

98105

Seattle Children's Hospital, Seattle

100034

Peking University First Hospital, Beijing

100045

Beijing Children Hospital, Capital Medical University, Beijing

100080

Chinese PLA General Hospital, Beijing

130028

First Hospital of Jilin University, Changchun

330000

Jiangxi Provincial Children's Hospital, Jiangxi

550004

The Affiliated Hospital of Guizhou Medical University, Guiyang

610000

Chengdu's Women and Children's Central Hospital, Chengdu

1170124

Department of Neurology and Sense Organs, AOU Policlinico di Bari, Bari

4920235

Schneider Children´s Medical Center, Petah Tikva

H2X 0C2

Hôtel Dieu de Montréal - CHUM, Montreal

H3T 1C5

CHU Sainte-Justine, Montreal

M5G 1X8

The Hospital for Sick Children, Toronto

M5T 2S8

Toronto Western Hospital, Toronto

V6H 3V4

BC Children's Hospital, Vancouver

01454

Epilepsiezentrum Kleinwachau gGmbH, Radeberg

00185

Policlinico Umberto I, Rome

08035

Hospital Universitari Vall d'Hebron, Barcelona

08950

Hospital Sant Joan de Déu, Barcelona

BS2 8AE

Bristol Royal Hospital for Children, Bristol

OX3 9DU

NHS acute tertiary referral centre, John Radcliffe Hospital, Oxford

M6 8HD

Salford Royal Hospital, Salford

S10 2TH

Sheffield Children's Hospital, Sheffield

Sponsors
All Listed Sponsors
lead

Marinus Pharmaceuticals

INDUSTRY

NCT05323734 - Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy | Biotech Hunter | Biotech Hunter