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NCT05716100 · ClinicalTrials.gov registry record · Phase 3
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
A Phase 3 study of Focal Onset Seizures, sponsored by Xenon Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT05716100: Recruiting Phase 3 study of Focal Onset Seizures, sponsored by Xenon Pharmaceuticals.
NCT05716100 is a Phase 3 study of Focal Onset Seizures that is actively recruiting participants, run by Xenon Pharmaceuticals. The registered enrollment target is 360 participants, above the 192-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (88% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05716100, a Phase 3 study of Focal Onset Seizures, is actively recruiting participants, sponsored by Xenon Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
The X-TOLE3 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)
California
- Rancho Research Institute - Downey
- University of California Los Angeles (UCLA) - Los Angeles
- University of California Irvine Health - Orange
Florida
- Panhandle Research and Medical Clinic - Gulf Breeze
- Mayo Clinic Florida - Jacksonville
Ohio
- Cleveland Clinic - Cleveland
- OhioHealth - Columbus
Other
- Hospital Ramos Mejia - Buenos Aires
- Hospital De Alta Complejidad en Red el Cruce - Buenos Aires
Arkansas
- Clinical Trials, Inc. - Little Rock
Idaho
- Consultants in Epilepsy and Neurology, PLLC - Boise
Illinois
- Southern Illinois University School of Medicine - Springfield
Maryland
- Mid-Atlantic Epilepsy and Sleep Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT05716100 shows while recruiting
NCT05716100 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (88% 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.
NCT05716100 names 20 study sites across 15 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05716100 about?
NCT05716100 is a clinical study titled "A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)". The X-TOLE3 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 NCT05716100?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2023-05-09. Estimated completion is 2026-12.
What conditions does trial NCT05716100 study?
This clinical trial studies the following conditions: Focal Onset Seizures.
What interventions are being tested in trial NCT05716100?
The interventions under investigation include: Placebo (DRUG), XEN1101 (DRUG).
Who is sponsoring clinical trial NCT05716100?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05716100 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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