Cenobamate Monotherapy
- Study HIC#:2000038428
- Last Updated:06/26/2025
The goal of this study is to see how effective cenobamate is as a standalone treatment for adult subjects who have recently been diagnosed with or have experienced a recurring partial-onset seizure. Cenobamate as a standalone treatment is approved by the U.S. Food and Drug Administration (FDA) for adult subjects who have recently been diagnosed with or have experienced a recurring partial-onset seizure; however, there is limited clinical data assessing its use as monotherapy in adults with partial-onset seizures. This study will explore the effectiveness of doses of 100 mg/day and 200 mg/day in this specific population.
Clinicaltrials.gov website:
Sponsor Website:
- Age18 years - 74 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Divya Bhaskar, Study Coordinator
- Phone Number: 1-203-785-3865
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Male or female, 18- 74 years of age
Diagnosis of partial-onset seizures with motor signs:
Either newly diagnosed or previously diagnosed with:
At least 2 unprovoked seizures (at least >24 hours apart) within the past year prior, of which at least 1 unprovoked seizure (but below 20 seizures) occurred in the past 12 weeks
OR
1 unprovoked seizure within the past 12 weeks with an increased risk of a second seizure
Exclusion
-Participants who have seizure clusters where individual seizures cannot be counted
-Participants cannot be pregnant or breastfeeding or planning to get pregnant during the study; if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to the study, and 2 weeks after the last dose of study drug
-Participants who have a history of status epilepticus that required hospitalization within the past year
-Participants taking phenytoin, phenobarbital, carbamazepine, or rifampin on a regular basis.
