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NCT06453213 · ClinicalTrials.gov registry record · Phase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
A Phase 4 study of Focal Onset Seizure, sponsored by SK Life Science.
- Active
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
- 19
- Study locations
NCT06453213: Active Phase 4 study of Focal Onset Seizure, sponsored by SK Life Science.
NCT06453213 is a Phase 4 study of Focal Onset Seizure that is active but no longer recruiting, run by SK Life Science. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06453213, a Phase 4 study of Focal Onset Seizure, is active but no longer recruiting, sponsored by SK Life Science.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
- 19
- Study locations
Study Summary
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.
Primary Outcome
The number (percentage) of subjects with POS who achieved seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period.
Conditions Studied
Interventions
- DRUG Cenobamate
Study Locations (19)
Arizona
- Arizona Neuroscience Research - Phoenix
- Center For Neurosciences - Tucson
California
- Neuro Pain Medical Center - Fresno
- Hoag Physician Partners - Newport Beach
Connecticut
- Hartford Hospital - Hartford
- Yale School of Medicine - Yale-New Haven Hospital - New Haven
Florida
- Elite Clinical Research - Miami
- Knight Neurology - Rockledge
Michigan
- Henry Ford Health System - Detroit
- Wayne Neurology PLC - Plymouth
New York
- NY Neurology Associates - New York
- Mount Sinai Hospital - New York
Arkansas
- Clinical Trials Inc - Little Rock
Idaho
- Consultants In Epilepsy and Neurology - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2027-07-09 |
| Phase | Phase 4 |
What the registry record for NCT06453213 still lists
NCT06453213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Focal Onset Seizure appearing as the primary indexed condition, and to 1 intervention - of which Cenobamate is the first listed.
NCT06453213 lists 19 locations in 13 states (Arizona, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06453213 about?
NCT06453213 is a clinical study titled "Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy". 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 clinica...
What is the current status of trial NCT06453213?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2024-10-14. Estimated completion is 2027-07-09.
What conditions does trial NCT06453213 study?
This clinical trial studies the following conditions: Focal Onset Seizure.
What interventions are being tested in trial NCT06453213?
The interventions under investigation include: Cenobamate (DRUG).
Who is sponsoring clinical trial NCT06453213?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06453213 being conducted?
This trial has 19 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06453213's enrollment target sits among peer trials
49 1323rd of 2000 higher than 671 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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