Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

PHASE3CompletedINTERVENTIONAL
Enrollment

405

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

October 31, 2016

Conditions
Drug Resistant Partial Onset Seizure
Interventions
DRUG

ganaxolone

200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day

DRUG

Placebo

placebo

Trial Locations (71)

1000

Medical Center Excelsior 4, Sofia

1113

SHATNP, Sofia

1336

MHAT Lyulin Department of Neurology, Sofia

1431

UMHAT Alexandrovska Clinic of Nerve Diseases, Sofia

2031

The Prince of Wales Hospital, Randwick

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2700

MHAT, Blagoevgrad

3050

The Royal Melbourne Hospital, Parkville

3065

St. Vincent's Hospital, Fitzroy

3084

The Florey Institute of Neuroscience and Mental Health, Heidelberg

5042

Flinders Medical Center, Bedford Park

5800

UMHAT Dr. Georgi Stranski Clinic of Neurology, Pleven

7000

Medical Centre-Teodora, Rousse

9000

Medical Center Ekvita Ltd, Varna

10016

New York University Comprehensive Epilepsy Center, New York

10017

Northeast Regional Epilepsy Group, New York

10941

Northeast Regional Epilepsy Group, Middletown

11501

Winthrop University Hospital, Mineola

11516

Five Towns Neuroscience Research, Cedarhurst

16321

Epilepsieklinik, Bernau

19107

Jefferson Comprehensive Epilepsy Center, Philadelphia

19140

Temple University School of Medicine, Philadelphia

20817

Mid-Atlantic Epilepsy Center, Bethesda

27157

Wake Forest Health Sciences, Winston-Salem

33176

Neuroscience Consulants, Miami

33617

Krankenhaus Mara Epilepsie-Zentrum, Bielefeld

33952

Medsol Clinical Research Center, Port Charlotte

35043

Universitatsklinikum GieBen und Marburg, Marburg

35294

University of Alabama at Birmingham, Birmingham

40212

Neuro-Consil, Dussseldorf

40504

Bluegrass Epilepsy Research, LLC, Lexington

43221

Ohio State University, Columbus

44718

Ohio Clinical Research Partners, LLC, Canton

53105

Klinik fur Epileptologie, Bonn

55422

Minneapolis Clinic of Neurology, Golden Valley

63017

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield

72205

Clinical Trials Inc., Little Rock

73112

Lynn Health Institute, Oklahoma City

Sooner Clinical Research, Oklahoma City

75231

Neurology Consultants of Dallas, Dallas

75251

Texas Epilepsy Group, Dallas

80045

University of Colorado- Anschutz Outpatient Pavilion, Aurora

83702

Consultants in Epilepsy & Neurology, Boise

85004

Xenoscience Inc., Phoenix

85351

The MORE Foundation, Sun City

89081

Universitatsklin Kum Ulm, Ulm

90404

Neurological Research Institute, Santa Monica

93710

Neuro-Pain Medical Center, Inc, Fresno

98057

Rainier Clinical Research Center, Inc., Renton

107150

Moscow

117049

Moscow

150030

Yaroslavl

192019

Saint Petersburg

194291

Saint Petersburg

420064

Kazan State Medical University, Kazan'

443095

Samara

603163

Nizhny Novgorod

630054

Novosibirsk

630091

City Neurological Center, Novosibirsk

35294-3280

University of Alabama Epilepsy Center, Birmingham

02115

Bringham and Women's Hospital, Boston

08103

Cooper Medical Center of Rowan University, Camden

07601

Northeast Regional Epilepsy Group, Hackensack

Unknown

Novo-Med, Jaworowa

Centrum Medycne Dendryt, Katowice

Indywidualna Praktyka ul Narutowicza, Lublin

Wojewodzki Szpital Specjalistyczny Oddzial, Lublin

Fundacja Epileptologii Wiertnicza, Warsaw

Instytut Psychiatrii i Neurologii, Warsaw

Saint Petersburg

Sponsors
All Listed Sponsors
lead

Marinus Pharmaceuticals

INDUSTRY

NCT01963208 - Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension | Biotech Hunter | Biotech Hunter