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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: Recruiting Phase 3 study of Partial Epilepsy, sponsored by SK Life Science.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.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
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What NCT05067634 shows while recruiting
NCT05067634 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 501-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (72% lower).
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 names 20 study sites across 14 states, led by 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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