Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

September 21, 2018

Primary Completion Date

May 26, 2025

Study Completion Date

May 26, 2025

Conditions
Primary Generalized Epilepsy
Interventions
DRUG

Cenobamate

12.5 mg tablet, 25 mg tablet, 50 mg tablet, 100 mg tablets, 150 mg tablets, 200 mg tablets. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

DRUG

Placebo

Matching Placebo

Trial Locations (116)

1083

Semmelweis Egyetem, Budapest

1336

MHAT Lyulin EAD, Sofia

1407

Acibadem City Clinic MHAT Tokuda EAD, Sofia

1408

Diagnostic Consultative Center Neoclinic EAD, Sofia

2700

Multiprofile Hospital for Active Treatment Puls AD, Blagoevgrad

3084

Austin Health, Heidelberg

4101

Children's Health Queensland Hospital, South Brisbane

5000

Medical Center Medica Plus OOD, Veliko Tarnovo

5100

MHAT Sv. Ivan Rilski Gorna Oryahovitsa EOOD, Gorna Oryahovitsa

6800

Csongrád Megyei Egészségügyi Elláto Központ Ideggyógyászati Osztály, Hódmezővásárhely

7002

UMHAT Kanev AD, Rousse

9000

Diagnostic Consultative Center Equita EOOD, Varna

11215

New York Presbyterian Hospital, Brooklyn

11598

Five Towns Neuroscience Research, Woodmere

13353

Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum, Berlin

14203

UBMD Neurology, Buffalo

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19140

Temple University Lewis Katz School of Medicine, Philadelphia

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

21005

Municipal Non-profit Enterprise Vinnytsia Regional Clinical Psychoneurological Hospital named after Acad. O.I. Yushchenko of Vinnytsia Regional Council, Department of Neurology #3, Vinnytsia

24016

Carilion Clinic, Roanoke

24105

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel

27710

Duke University Children's Health Center, Durham

28040

Hospital Clínico San Carlos, Madrid

29011

Hospital Regional Universitario de Malaga, Málaga

30328

Clinical Integrative Research Center of Atlanta, CIRCA, Atlanta

30329

Children's Healthcare of Atlanta, Atlanta

32803

Florida Hospital Medical Group, Orlando

33176

Brainstorm Research, Miami

33606

University of South Florida, Tampa

36000

Communal Enterprise Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev of Poltava Regional Council, Poltava

37232

Vanderbilt University Medical Center, Nashville

38105

LeBonheur Children's Medical Center, Memphis

40536

University of Kentucky, Lexington

43214

Ohio Health Research and Innovation Institute, Columbus

43606

University of Toledo, Toledo

46020

Municipal Non-Profit Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Neurology #2, Ternopil

46026

Hospital Universitario La Fe, Valencia

46202

Indiana University, Indianapolis

48824

Michigan State University, East Lansing

49000

Communal Enterprise Regional Medical Center of Family Health of the Dnipropetrovsk Regional Council, Dnipro

49005

Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Regional Center of Psychosomatic Disorders based on Psychoneurology Department, Dnipro

Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Dnipropetrovsk

49009

Communal Non-commercial Enterprise City Children's Clinical Hospital 6 of Dnipro City Council, Dnipro

49069

Municipal Non-profit Enterprise City Clinical Hospital No.16 of Dnipro City Council, Department of Neurology, Dnipro

50010

PMG Research of McFarland Clinic, Ames

55422

Minneapolis Clinic of Neurology Golden Valley, Golden Valley

55905

Mayo Clinic - Rochester, Rochester

60612

Rush University, Chicago

61068

Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional Clinical Psychiatric Hospital #3, Kharkiv

65025

Municipal Non-Profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of Cerebro-Vascular Diseases with Neurosurgery, Odesa

65201

University of Missouri Health Care, Columbia

67513

Communal Non-Profit Enterprise Odesa Regional Medical Centre of Mental Health Odesa Regional Council, Department #2, Odesa

Odessa Regional Psychiatric Hospital No. 2,, Odesa

69600

Municipal Non-Profit Enterprise Zaporizhzhia Regional Clinical Hospital Of Zaporizhzhia Regional Council, Zaporizhzhya

76011

Municipal Non-profit Enterprise Prykarpattia Regional Clinical Center for Mental Health of Ivano-Frankivsk Regional Council, Ivano-Frankivsk

77030

Baylor College of Medicine, Houston

78757

Child Neurology Consultants of Austin, Austin

79010

Communal Non-Profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Neurological Department, Antiepileptic Center, Lviv

79912

ANRC Research, El Paso

80045

Children's Hospital of Colorado, Grand Junction

80907

Colorado Springs Neurological Associates, Colorado Springs

83702

Consultants in Epilepsy and Neurology, Boise

84113

University of Utah / Primary Children's Hospital, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

85718

Center for Neurosciences, Tucson

88018

Municipal Non-profit Enterprise Regional Clinical Center of Neurosurgery and Neurology of Zakarpattia Regional Council, Department of Neurosurgery #2, Uzhhorod

93710

Neuro Pain Medical Center, Fresno

96814

Hawaii Pacific Neuroscience, Honolulu

98057

Valley Medical Center, Renton

99204

MultiCare Institute for Research and Innovation, Spokane

04074

Maine Medical Center, Scarborough

08818

JFK Medical Center- The Neuroscience Institute, Edison

07601

Northeast Regional Epilepsy Group, Hackensack

08901

Saint Peter's University Hospital, New Brunswick

150 06

Fakultní nemocnice v Motole, Prague

656 91

Fakultni nemocnice u sv. Anny v Brne, 1. Neurologicka klinika, Brno

500 03

Nestatni zdravotnicke zarizeni, privatni ordinance neurologie, Hradec Králové

708 52

Cerebrovaskularni poradna, s.r.o., Ostrava-Poruba

703 00

Cerebovaskularni poradna s.r.o., Ostrava-Vitkovice

160 00

Forbeli s.r.o., Neurologicka ordinace, Prague

516 01

Vestra Clinics, s.r.o., Rychnov nad Kněžnou

760 01

Neurologicka ambulance MUDr.Monika Zahumenska, Zlín

0159

LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry, Tbilisi

0186

Institute of Neurology and Neuropsychology LTD, Tbilisi

Unknown

Universitätsklinikum Jena, Jena

Debreceni Egyetem Klinikai Központ, Gyermekgyógyászati Intézet Nagyerdei krt. 98, Debrecen

Centrum Medyczne Plejady, Krakow

Wojewódzki Specjalistyczny Szpital Dziecięcy im. sw. Ludwika sw Krakowie, Krakow

Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia Padaczki, Kielce

Narodny Ustav Detskych Chorob, Bratislava

CHA Bundang Medical Center, Seongnam-si

SMG-SNU Boramae Medical Center, Seoul

Chungbuk National University Hospital, Cheongju-si

Ajou University Hospital, Suwon

01454

Sächsisches Epilepsiezentrum Kleinwachau gGmbH, Radeberg

60-848

Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R sp. k, Poznan

95-054

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J., Ksawerów

31-209

Centrum Leczenia Padaczki i Migreny, Krakow

55-040

NZOZ Poradnia Zdrowia Psychicznego Antonijczuk Boleslaw, Tyniec Mały

52-416

Centrum Medyczne Oporów, Wroclaw

20-090

Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie, Lublin

01-868

Centrum Medyczne Warszawa Pratia s.a, Warsaw

40-081

Centrum Medyczne Pratia Katowice, Katowice

40-571

M.A. LEK A.M. Maciejowscy S.C Centrum Terapii SM, Katowice

40-635

Gornoslaskie Centrum Medyczne - Samodzielny Publiczny Szpital Kliniczny Number 7, Katowice

40-650

Niepubliczny Zaklad Opieki Zdrowotnej Novo-Med, Katowice

40-851

Gyncentrum Clinic Sp. z.o.o, Katowice

10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn

018 41

Konzílium, s.r.o, Dubnica nad Váhom

974 04

MUDr. Beata Dupejova, neurologická ambulncia, s.r.o, Banská Bystrica

085 01

IN MEDIC s.r.o, Bardejov

026 01

MEDBAJ, s.r.o., Neurologicka ambulancia, Nemocnicna 1944/10, Dolný Kubín

053 42

NEURES, s.r.o.-Neurologická Ambulancia, Krompachy

02192

Kyiv City Psychoneurological Hospital №2, Kiev

All Listed Sponsors
lead

SK Life Science, Inc.

INDUSTRY

NCT03678753 - Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures | Biotech Hunter | Biotech Hunter