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Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
NCT06453213 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06453213
The ClinicalTrials.gov registry entry for NCT06453213 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06453213 reports 19 study locations spanning 13 distinct geographic areas — top geographies include Arizona, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06453213?
The interventions under investigation include: Cenobamate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06453213?
This trial is sponsored by SK Life Science, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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