Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
NCT05716100 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05716100
The ClinicalTrials.gov registry entry for NCT05716100 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 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xenon Pharmaceuticals, which has 8 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 Focal Onset Seizures appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT05716100 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Ohio. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05716100?
The interventions under investigation include: Placebo (DRUG), XEN1101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05716100?
This trial is sponsored by Xenon Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.