A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

ClinicalTrials.gov ID: NCT05716100

Public ClinicalTrials.gov record NCT05716100. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 20, 2026, 10:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Study identification

NCT ID: NCT05716100
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Xenon Pharmaceuticals Inc.; Industry
Enrollment: 360 participants

Conditions and interventions

Conditions

Focal Onset Seizures

Interventions

Placebo Drug
XEN1101 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 8, 2023
Primary completion: Sep 30, 2026
Completion: Nov 30, 2026
Last update posted: May 13, 2026

2023 – 2026

United States locations

U.S. sites: 19
U.S. states: 15
U.S. cities: 19

Facility	City	State	ZIP	Site status
Clinical Trials, Inc.	Little Rock	Arkansas	72205	Recruiting
Rancho Research Institute	Downey	California	90242	Recruiting
University of California Los Angeles (UCLA)	Los Angeles	California	90095	Recruiting
University of California Irvine Health	Orange	California	92868	Recruiting
Panhandle Research and Medical Clinic	Gulf Breeze	Florida	32651	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	32224	Recruiting
Consultants in Epilepsy and Neurology, PLLC	Boise	Idaho	83702	Recruiting
Southern Illinois University School of Medicine	Springfield	Illinois	62794	Recruiting
Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	20817	Recruiting
9D University Health Center	Detroit	Michigan	48201	Recruiting
Northeast Regional Epilepsy Group	Hackensack	New Jersey	07601	Recruiting
Five Towns Neuroscience Research	Woodmere	New York	11598	Withdrawn
Duke University Clinic	Durham	North Carolina	27705	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
OhioHealth	Columbus	Ohio	43214	Recruiting
Providence Neurological Specialities	Portland	Oregon	97225	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting
Austin Epilepsy Care Center	Austin	Texas	78758	Recruiting
University of Utah Clinical Neurosciences Center	Salt Lake City	Utah	84132	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05716100, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 13, 2026 · Synced May 20, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05716100 live on ClinicalTrials.gov.

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