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NCT05067634 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Partial Epilepsy, sponsored by SK Life Science.

Recruiting
Registry status
Phase 3
Development phase
140
Enrollment target
20
Study locations

NCT05067634 is a Phase 3 study of Partial Epilepsy that is actively recruiting participants, run by SK Life Science. The registered enrollment target is 140 participants, below the 501-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05067634, a Phase 3 study of Partial Epilepsy, is actively recruiting participants, sponsored by SK Life Science.

RECRUITING
Registry status
Phase 3
Development phase
140 participants
Enrollment target
20
Study locations

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

25 total trials

What the Registry Record Tells You About NCT05067634

The ClinicalTrials.gov registry entry for NCT05067634 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 501-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (72% lower). The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.

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.

NCT05067634 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Georgia, Ohio, California.

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.

What interventions are being tested in trial NCT05067634?

The interventions under investigation include: Xcopri (DRUG).

Who is sponsoring clinical trial NCT05067634?

This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.