Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Public ClinicalTrials.gov record NCT06453213. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06453213
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2024 (Actual)
- Primary completion
- May 26, 2027 (Estimated)
- Completion
- Jul 9, 2027 (Estimated)
- Last update posted
- Oct 27, 2026
2024 – 2027
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Neuroscience Research | Phoenix | Arizona | 85032 | — |
| Center For Neurosciences | Tucson | Arizona | 85718 | — |
| Clinical Trials Inc | Little Rock | Arkansas | 72205 | — |
| Neuro Pain Medical Center | Fresno | California | 93710 | — |
| Hoag Physician Partners | Newport Beach | California | 92663 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale School of Medicine - Yale-New Haven Hospital | New Haven | Connecticut | 06519 | — |
| Elite Clinical Research | Miami | Florida | 33144 | — |
| Knight Neurology | Rockledge | Florida | 32955 | — |
| Consultants In Epilepsy and Neurology | Boise | Idaho | 83702 | — |
| Bluegrass Epilepsy Research LLC | Lexington | Kentucky | 40504 | — |
| Louisiana State University Health Sciences | Shreveport | Louisiana | 71103 | — |
| John Hopkins Epilepsy Center | Baltimore | Maryland | 21287 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Wayne Neurology PLC | Plymouth | Michigan | 48170 | — |
| University of Missouri Health Care | Columbia | Missouri | 65212 | — |
| NY Neurology Associates | New York | New York | 10003 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06453213, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2026 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06453213 live on ClinicalTrials.gov.