Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

PHASE4RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 14, 2024

Primary Completion Date

May 26, 2027

Study Completion Date

July 9, 2027

Conditions
Focal Onset Seizure
Interventions
DRUG

Cenobamate

"The 100 mg/ day Treatment Period includes a 6-week Titration Phase and a 26-week Maintenance Phase. During the Titration Phase subjects will be treated with cenobamate 12.5 mg/day for two weeks, 25 mg/day for two weeks and 50 mg/day for two weeks. Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mg/day in the Maintenance Phase for 26 weeks. If the subject does not experience a certain type of seizure in the 100 mg/day Maintenance Phase, he/she can enter the Optional Extension Period (100 mg/day).~The 200 mg/day treatment period consists of a 2-week Titration Phase and a 26-week Maintenance Phase. During the 2-week Titration Phase, subjects will receive cenobamate 150 mg/day before entering the 26-week 200 mg/day Maintenance Phase. If the subject does not experience a certain type of seizure during the 200 mg/day Maintenance Phase, he/she can enter the 26 week Optional Extension Period (200 mg/day)."

Trial Locations (40)

10003

RECRUITING

NY Neurology Associates, New York

10029

RECRUITING

Mount Sinai Hospital, New York

15212

RECRUITING

Allegheny Neurological Associates, Pittsburgh

19107

RECRUITING

Thomas Jefferson University, Philadelphia

20037

RECRUITING

The George Washington University Hospital, Washington D.C.

20817

RECRUITING

Midatlantic Epilepsy and Sleep Center, Bethesda

21287

RECRUITING

John Hopkins Epilepsy Center, Baltimore

22601

RECRUITING

Virginia Epilepsy and Neurodevelopmental Clinic, Winchester

30912

RECRUITING

Augusta University, Augusta

32955

RECRUITING

Knight Neurology, Rockledge

33144

RECRUITING

Elite Clinical Research, Miami

33176

WITHDRAWN

Serenity Research Center, Miami

34741

WITHDRAWN

Neurology Consultants of Central Florida, Kissimmee

37232

RECRUITING

Vanderbilt Epilepsy Clinic, Nashville

40504

RECRUITING

Bluegrass Epilepsy Research LLC, Lexington

43214

RECRUITING

Ohio Health Research Institute, Columbus

48170

RECRUITING

Wayne Neurology PLC, Plymouth

48202

RECRUITING

Henry Ford Health System, Detroit

53226

RECRUITING

Froedtert and The Medical College of Wisconsin, Milwaukee

55113

RECRUITING

Minnesota Epilepsy Group, Roseville

60612

RECRUITING

RUSH Neurology Epilepsy, Chicago

65212

RECRUITING

University of Missouri Health Care, Columbia

66160

RECRUITING

The University of Kansas Hospital, Kansas City

70043

WITHDRAWN

New England Institute for Clinical Research, Chalmette

71103

RECRUITING

Louisiana State University Health Sciences, Shreveport

72205

RECRUITING

Clinical Trials Inc, Little Rock

77429

WITHDRAWN

Northwest Houston Neurology, Cypress

78539

RECRUITING

DHR Health Institute for Research and Development, Edinburg

83702

RECRUITING

Consultants In Epilepsy and Neurology, Boise

84132

RECRUITING

University of Utah, Salt Lake City

85032

RECRUITING

Arizona Neuroscience Research, Phoenix

85718

RECRUITING

Center For Neurosciences, Tucson

90242

RECRUITING

Rancho Los Amigos National Rehabilitation Center, Downey

92663

RECRUITING

Hoag Physician Partners, Newport Beach

93710

RECRUITING

Neuro Pain Medical Center, Fresno

06102

RECRUITING

Hartford Hospital, Hartford

06519

RECRUITING

Yale School of Medicine - Yale-New Haven Hospital, New Haven

02035

WITHDRAWN

Neurology Center of New England P.C., Foxborough

07601

RECRUITING

Northeast Regional Epilepsy Group, Hackensack

07901

RECRUITING

Overlook Medical Center, Summit

All Listed Sponsors
lead

SK Life Science, Inc.

INDUSTRY

NCT06453213 - Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy | Biotech Hunter | Biotech Hunter