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NCT05614063 · ClinicalTrials.gov registry record · Phase 3
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
A Phase 3 study of Focal Onset Seizures, sponsored by Xenon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT05614063: Completed Phase 3 study of Focal Onset Seizures, sponsored by Xenon Pharmaceuticals.
NCT05614063 is a Phase 3 study of Focal Onset Seizures that has completed, run by Xenon Pharmaceuticals. The registered enrollment target is 380 participants, above the 187-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05614063, a Phase 3 study of Focal Onset Seizures, has completed, sponsored by Xenon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
Study Summary
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG XEN1101
Study Locations (20)
Florida
- Serenity Research - Miami
- Research Institute of Orlando, LLC - Orlando
- Panhandle Research & Medical Clinic - Pensacola
- Medsol Clinical Research Center - Port Charlotte
- University of South Florida - Tampa
- Encore Medical Research of Weston, LLC - Weston
Arizona
- Xenoscience - Phoenix
- University of Arizona, Health Sciences Center - Tucson
California
- Brain Science Research Institute - Los Angeles
- University of California, David Clinical & Translational Science Center Clinical Research (CCRC) - Sacramento
Kentucky
- Bluegrass Epilepsy Research, LLC - Lexington
- University of Kentucky, Dept. of Neurology - Lexington
Alabama
- Strada Patient Care Center - Mobile
Arkansas
- Clinical Trials, Inc - Little Rock
Colorado
- Anschutz Health Sciences - Aurora
Georgia
- Emory Brain Health Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 3 |
What the finished NCT05614063 record still lists
NCT05614063 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, above the 187-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (103% higher).
The record links to 1 condition, with Focal Onset Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05614063 names 20 study sites across 12 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05614063 about?
NCT05614063 is a clinical study titled "A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures". The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
What is the current status of trial NCT05614063?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2022-11-18. Estimated completion is 2026-02-03.
What conditions does trial NCT05614063 study?
This clinical trial studies the following conditions: Focal Onset Seizures.
What interventions are being tested in trial NCT05614063?
The interventions under investigation include: Placebo (DRUG), XEN1101 (DRUG).
Who is sponsoring clinical trial NCT05614063?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05614063 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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