To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2024

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Refractory Status Epilepticus
Interventions
DRUG

Ganaxolone

Ganaxolone will be administered as IV solution.

DRUG

Placebo

Placebo will be administered as IV solution.

DRUG

Standard of care

A non-anesthetic medication not previously used for treatment of SE within the current episode and will be administered at a dose sufficient for the termination of SE according to investigator judgment.

Trial Locations (52)

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

1070

Hôpital Universitaire de Bruxelles - Hôpital Erasme, Brussels

1145

National Institute of Clinical Neurosciences, Budapest

1205

Hôpitaux Universitaires de Genève (HUG), Geneva

2650

UZA University Hospital Antwerpen, Edegem

3000

University Hospitals Leuven, Leuven

4020

Kepler University Hospital, Linz

4021

Kepler Universitätsklinikum GmbH, Linz

10000

Dubrava University Hospital, Zagreb

University Hospital Centre Zagreb, Zagreb

12000

Hadassah Medical Center, Jerusalem

20123

Università Cattolica del Sacro Cuore, Milan

28040

Hospital Clinico San Carlos Madrid., Madrid

29010

Hospital Regional Universitario de Málaga, Málaga

31059

Chu de Toulouse, Toulouse

35043

Epilepsy Center Hessen, Marburg

37126

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

41100

Azienda Ospedaliera Universitaria di Modena, Modena

49074

University of Osnabruck, Dep of Neurology, Osnabrück, Osnabrück

50134

Azienda Ospedaliero Universitaria Caregg, Florence

52621

Sheba Medical Center, Tel Aviv

54000

CHRU Nancy, Nancy

59037

Hopital R. Salengro, Lille

60200

Mazaryk University, Brno,The First Department of Neurology, Brno

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

69002

Hospices Civils de Lyon, Lyon

70210

Kuopio University Hospital, Kuopio

70852

University Hospital Ostrava, Ostrava

91054

Universitätsklinikum Erlangen, Erlangen

898081

Universität- und Rehabilitationskliniken Ulm, RKU, Ulm

8410100

Soroka Medical Center, Beersheba

A-6020

Medical University of Innsbruck, Innsbruck

A-5020

Paracelsus Medical University Salzburg, Christian Doppler University Hospital, Department of Neurology, Salzburg

A-1090

Medical University Vienna, Vienna

150 06

Motol University Hospital, Prague

00290

Helsinki University Hospital, Helsinki

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

40-635

Oddział Neurologii z Pododdziałem Udarowym Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach, Katowice

30-688

Oddzial Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie, Krakow

40-752

Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskiego w Katowicach, Katowice

41-800

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu, Katowice

20-954

Samodzielny Publiczny Szpital Kliniczny, Lublin

51-149

WSS im Gromkowskiego, Wroclaw

975 17

II. Neurologická klinika SZU Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica, Banská Bystrica

826 06

SlovakiaNeurologická klinika SZU a UNB Nemocnica Ružinov Univerzitná nemocnica Bratislava, Bratislava

054 01

Neurologické oddelenie Nemocnica Agel Levoča a.s., Levoča

917 01

Neurologické oddelenie Fakultná nemocnica, Trnava

08004

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital Santa Creu i Sant Pau, Institut de Recerca Biomedica Sant Pau, Barcelona

CF14 4W

Cardiff and Vale UHB, Cardiff

Unknown

King's College Hospital, Department of Neurology, London

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors
All Listed Sponsors
lead

Marinus Pharmaceuticals

INDUSTRY

NCT05814523 - To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE) | Biotech Hunter | Biotech Hunter