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RECRUITING Phase 3

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

NCT05067634 · View on ClinicalTrials.gov ↗

Study Summary

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Conditions Studied

Interventions

  • DRUG Xcopri

Study Locations (20)

Georgia

  • Augusta University Medical Center — Augusta
  • Clinical Integrative Research Center of Atlanta — Sandy Springs
  • Meridian Clinical Research - Savannah Neurology Specialists — Savannah

Ohio

  • Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology — Akron
  • Cincinnati Children's Hospital — Cincinnati
  • Cleveland Clinic Main Campus — Cleveland

California

  • Lucile Packard Children's Hospital Stanford — Palo Alto
  • University of California Davis Health — Sacramento

New Jersey

  • Northeast Regional Epilepsy Group — Hackensack
  • Northeast Regional Epilepsy Group - Morristown — Morristown

Arizona

  • Phoenix Children's Hospital — Phoenix

Connecticut

  • Connecticut Children's Medical Center — Hartford

Kentucky

  • Kentucky Clinic — Lexington

Maryland

  • Mid-Atlantic Epilepsy and Sleep Center — Bethesda

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2022-01-14
Est. Completion 2026-07
Phase Phase 3

Sponsor

SK Life Science

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05067634

The ClinicalTrials.gov registry entry for NCT05067634 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 140 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 Partial Epilepsy appearing as the primary indexed condition, and to 1 intervention — of which Xcopri 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: NCT05067634 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Georgia, Ohio, California. 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 NCT05067634 about?

NCT05067634 is a clinical study titled "Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures". Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

What is the current status of trial NCT05067634?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2022-01-14. Estimated completion is 2026-07.

What conditions does trial NCT05067634 study?

This clinical trial studies the following conditions: Partial Epilepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05067634?

The interventions under investigation include: Xcopri (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05067634?

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 NCT05067634 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial