RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Official Title

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

Quick Facts

Study Start:2024-10-14

Study Completion:2027-07-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06453213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them. 2. Male or female subjects 18-74 years of age with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures. Diagnosis will be established by clinical history and an electroencephalogram (EEG) consistent with POS. Subjects with a normal EEG could be included provided they met the other diagnostic criteria according to clinical history. 3. Subjects who are newly diagnosed or have recurrent epilepsy and have experienced at least 2 unprovoked seizures separated by a minimum of 24 hours in the 1 year prior to Day 1 of the Treatment Period, of which, at least 1 unprovoked seizure (but below 20 seizures) occurred in the 12 weeks prior to Day 1 of the Treatment Period. Subjects with only 1 unprovoked seizure within the 12 weeks prior to Day 1 of the Treatment Period can be included if information is available to indicate that risk for a second seizure exceeds that which is usually considered to be epilepsy (about 60%). In the absence of clear information about recurrence risk, or even knowledge of such information, the default definition of epilepsy originates at the second unprovoked seizure. Subjects who are newly diagnosed and have been prescribed low dose of 1 ASM for ≤4 weeks can be included if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks of 1st dose of cenobamate. For subjects with recurrent epilepsy, they must have relapsed at least 2 years after the end of the last ASM treatment but can have been prescribed a low dose of 1 ASM for ≤4 weeks if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks of 1st dose of cenobamate. 4. Female subjects are either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 2 weeks after last dose of study drug. 5. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study. 6. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.	1. Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs. 2. Subjects who have seizure clusters where individual seizures cannot be counted. 3. Subjects who present with or have a history of Lennox-Gastaut syndrome. 4. Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the Treatment Period. 5. Subjects who have a history of psychogenic non-epileptic seizures within 2 years prior to Day 1 of the Treatment Period. 6. Subjects who have a history of active suicidal ideation within the last 6 months or suicide attempt within 2 years prior to Day 1 of Treatment Period. 7. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, psychiatric, other neurological) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments. 8. History of Familial Short QT syndrome or prior subject diagnosis of Short QT syndrome. 9. Evidence of clinically significant active renal or hepatic disease. 10. Subjects taking a strong CYP3A inducer such as phenytoin, phenobarbital, carbamazepine, or rifampin within 12 weeks prior to the Pretreatment Period unless emergency care was needed due to the subject experiencing status epilepticus, uncontrolled seizures, or clusters of seizures. 11. Subjects who are taking more than one of the following centrally acting drugs: antipsychotic, antidepressant, or anxiolytic. The dose should be stable for the 12 weeks prior to the Pretreatment Period. 12. Subjects who have a history of any type of surgery for brain or central nervous system within 1 year prior to the Pretreatment Period. 13. Subjects who have a history of receiving any ASM (including ASM used as rescue treatment) for more than 4 weeks in total within 2 years prior to Day 1 of the Treatment Period. 14. Subjects who have used intermittent rescue medicine on 2 or more occasions within 4 weeks before the Pretreatment Period (1 to 2 doses over a 24-hour period considered one-time rescue). 15. Subjects who have a history of receiving any ASM polytherapy (\> 2 ASMs) during a previous episode of epilepsy. 16. Previous exposure to cenobamate or sensitivity/allergy to components of the oral tablets. 17. Subjects who have a history of drug or alcohol dependency or abuse within the last 2 years before the Pretreatment Period. 18. Subjects who have had multiple drug allergies or a severe drug reaction, including dermatological (eg, DRESS syndrome, Stevens-Johnson syndrome), hematological, or organ toxicity reactions. 19. Females who are breastfeeding or pregnant or planning to get pregnant in the Pretreatment Period or during the conduct of the study. 20. Subjects who have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer. 21. Subjects with dementia. 22. Subjects who have seizures due to a progressive CNS condition.

Inclusion Criteria

Exclusion Criteria

1. Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them.
2. Male or female subjects 18-74 years of age with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures. Diagnosis will be established by clinical history and an electroencephalogram (EEG) consistent with POS. Subjects with a normal EEG could be included provided they met the other diagnostic criteria according to clinical history.
3. Subjects who are newly diagnosed or have recurrent epilepsy and have experienced at least 2 unprovoked seizures separated by a minimum of 24 hours in the 1 year prior to Day 1 of the Treatment Period, of which, at least 1 unprovoked seizure (but below 20 seizures) occurred in the 12 weeks prior to Day 1 of the Treatment Period. Subjects with only 1 unprovoked seizure within the 12 weeks prior to Day 1 of the Treatment Period can be included if information is available to indicate that risk for a second seizure exceeds that which is usually considered to be epilepsy (about 60%). In the absence of clear information about recurrence risk, or even knowledge of such information, the default definition of epilepsy originates at the second unprovoked seizure. Subjects who are newly diagnosed and have been prescribed low dose of 1 ASM for ≤4 weeks can be included if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks of 1st dose of cenobamate. For subjects with recurrent epilepsy, they must have relapsed at least 2 years after the end of the last ASM treatment but can have been prescribed a low dose of 1 ASM for ≤4 weeks if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks of 1st dose of cenobamate.
4. Female subjects are either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 2 weeks after last dose of study drug.
5. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
6. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.

1. Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs.
2. Subjects who have seizure clusters where individual seizures cannot be counted.
3. Subjects who present with or have a history of Lennox-Gastaut syndrome.
4. Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the Treatment Period.
5. Subjects who have a history of psychogenic non-epileptic seizures within 2 years prior to Day 1 of the Treatment Period.
6. Subjects who have a history of active suicidal ideation within the last 6 months or suicide attempt within 2 years prior to Day 1 of Treatment Period.
7. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, psychiatric, other neurological) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
8. History of Familial Short QT syndrome or prior subject diagnosis of Short QT syndrome.
9. Evidence of clinically significant active renal or hepatic disease.
10. Subjects taking a strong CYP3A inducer such as phenytoin, phenobarbital, carbamazepine, or rifampin within 12 weeks prior to the Pretreatment Period unless emergency care was needed due to the subject experiencing status epilepticus, uncontrolled seizures, or clusters of seizures.
11. Subjects who are taking more than one of the following centrally acting drugs: antipsychotic, antidepressant, or anxiolytic. The dose should be stable for the 12 weeks prior to the Pretreatment Period.
12. Subjects who have a history of any type of surgery for brain or central nervous system within 1 year prior to the Pretreatment Period.
13. Subjects who have a history of receiving any ASM (including ASM used as rescue treatment) for more than 4 weeks in total within 2 years prior to Day 1 of the Treatment Period.
14. Subjects who have used intermittent rescue medicine on 2 or more occasions within 4 weeks before the Pretreatment Period (1 to 2 doses over a 24-hour period considered one-time rescue).
15. Subjects who have a history of receiving any ASM polytherapy (\> 2 ASMs) during a previous episode of epilepsy.
16. Previous exposure to cenobamate or sensitivity/allergy to components of the oral tablets.
17. Subjects who have a history of drug or alcohol dependency or abuse within the last 2 years before the Pretreatment Period.
18. Subjects who have had multiple drug allergies or a severe drug reaction, including dermatological (eg, DRESS syndrome, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
19. Females who are breastfeeding or pregnant or planning to get pregnant in the Pretreatment Period or during the conduct of the study.
20. Subjects who have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
21. Subjects with dementia.
22. Subjects who have seizures due to a progressive CNS condition.

Contacts and Locations

Study Contact

Shelby Parilla

CONTACT

201-421-3824

sparilla@sklsi.com

Study Locations (Sites)

Arizona Neuroscience Research

Phoenix, Arizona, 85032

United States

Center For Neurosciences

Tucson, Arizona, 85718

United States

Clinical Trials Inc

Little Rock, Arkansas, 72205

United States

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242

United States

Neuro Pain Medical Center

Fresno, California, 93710

United States

Hoag Physician Partners

Newport Beach, California, 92663

United States

Hartford Hospital

Hartford, Connecticut, 06102

United States

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, 06519

United States

The George Washington University Hospital

Washington, District of Columbia, 20037

United States

Neurology Consultants of Central Florida

Kissimmee, Florida, 34741

United States

Elite Clinical Research

Miami, Florida, 33144

United States

Serenity Research Center

Miami, Florida, 33176

United States

Knight Neurology

Rockledge, Florida, 32955

United States

Augusta University

Augusta, Georgia, 30912

United States

Consultants In Epilepsy and Neurology

Boise, Idaho, 83702

United States

RUSH Neurology Epilepsy

Chicago, Illinois, 60612

United States

The University of Kansas Hospital

Kansas City, Kansas, 66160

United States

Bluegrass Epilepsy Research LLC

Lexington, Kentucky, 40504

United States

New England Institute for Clinical Research

Chalmette, Louisiana, 70043

United States

Louisiana State University Health Sciences

Shreveport, Louisiana, 71103

United States

John Hopkins Epilepsy Center

Baltimore, Maryland, 21287

United States

Midatlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817

United States

Neurology Center of New England P.C.

Foxboro, Massachusetts, 02035

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Wayne Neurology PLC

Plymouth, Michigan, 48170

United States

Minnesota Epilepsy Group

Roseville, Minnesota, 55113

United States

University of Missouri Health Care

Columbia, Missouri, 65212

United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601

United States

Overlook Medical Center

Summit, New Jersey, 07901

United States

NY Neurology Associates

New York, New York, 10003

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Ohio Health Research Institute

Columbus, Ohio, 43214

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Allegheny Neurological Associates

Pittsburgh, Pennsylvania, 15212

United States

Vanderbilt Epilepsy Clinic

Nashville, Tennessee, 37232

United States

Northwest Houston Neurology

Cypress, Texas, 77429

United States

DHR Health Institute for Research and Development

Edinburg, Texas, 78539

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Virginia Epilepsy and Neurodevelopmental Clinic

Winchester, Virginia, 22601

United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: SK Life Science, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14

Study Completion Date2027-07-09

Study Record Updates

Study Start Date2024-10-14

Study Completion Date2027-07-09

Terms related to this study

Additional Relevant MeSH Terms

Focal Onset Seizure