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Enrolling by invitation Phase 3 Interventional

An Open-label Study of XEN1101 in Epilepsy

ClinicalTrials.gov ID: NCT05718817

Public ClinicalTrials.gov record NCT05718817. 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.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 3:50 PM 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 Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

Study identification

NCT ID
NCT05718817
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Phase 3
Lead sponsor
Xenon Pharmaceuticals Inc.
Industry
Enrollment
880 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 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
Apr 25, 2023 (Actual)
Primary completion
Apr 2033 (Estimated)
Completion
Jun 2033 (Estimated)
Last update posted
Oct 8, 2026

2023 – 2033

United States locations

U.S. sites
54
U.S. states
28
U.S. cities
51
Facility City State ZIP Site status
Xenoscience Phoenix Arizona 85004 —
University of Arizona - Health Sciences Tucson Arizona 85724 —
Clinical Trials, Inc Little Rock Arkansas 72205 —
Brain Science Research Institute Los Angeles California 90025 —
UC Irvine Health Orange California 92868 —
University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC) Sacramento California 95817 —
University of Colorado Hospital Anschutz Outpatient Pavilion Aurora Colorado 80045 —
Mayo Clinic Florida Jacksonville Florida 32224 —
Serenity Research Center, LLC Miami Florida 33176 —
Research Institute of Orlando, LLC Orlando Florida 32806 —
Panhandle Research & Medical Clinic Pensacola Florida 10021 —
University of South Florida Tampa Florida 33606 —
Encore Medical Research of Weston, LLC Weston Florida 33331 —
Hawaii Pacific Neuroscience Honolulu Hawaii 96817 —
Consultants in Epilepsy and Neurology Boise Idaho 83704 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
The University of Kansas Medical Center Kansas City Kansas 66103 —
Bluegrass Epilepsy Research, LLC Lexington Kentucky 40504 —
Kentucky Clinic Lexington Kentucky 40536 —
MMP Neurology Scarborough Maine 04074 —
University of Maryland Medical Center Baltimore Maryland 21201 —
Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland 20817 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
UMass Chan Medical School Worcester Massachusetts 06155 —
University of Michigan Hospitals Ann Arbor Michigan 48109-2435 —
Wayne State University Detroit Michigan 48201 —
Michigan State University East Lansing Michigan 48824 —
Cornwell Health (Spectrum Health Hospitals) Grand Rapids Michigan 49503 —
Minneapolis Clinic of Neurology Burnsville Minnesota 55337 —
Saint Louis University Medical School St Louis Missouri 63104 —
Northeast Epilepsy Group Hackensack New Jersey 07601 —
Dent Neurosciences Research Center Buffalo New York 14226 —
New York University Comprehensive Epilepsy Center New York New York 10016 —
Mount Sinai Health New York New York 10029 —
SUNY Upstate Medical University Syracuse New York 13210 —
Montefiiore Medical Center The Bronx New York 10467 —
Onsite Clinical Solutions Charlotte North Carolina 28211 —
Duke University Durham North Carolina 27710 —
Meridian Clinical Research, LLC Raleigh North Carolina 27607 —
Summa Health Akron Ohio 44304 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State University Brain and Spine Hospital Columbus Ohio 43210 —
Providence Neurological Specialities Portland Oregon 97225 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Austin Epilepsy Care Center Austin Texas 78758 —
ANESC Research El Paso Texas 79912 —
UT Health San Antonio San Antonio Texas 78229 —
University of Utah Clinical Neurosciences Center Salt Lake City Utah 84132 —
Carilion Clinic Roanoke Virginia 24013 —
Sentara Neurology Specialists Virginia Beach Virginia 23456 —
University of Washington Main Hospital Seattle Washington 10012 —
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215 —

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 98 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05718817, 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 Oct 8, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05718817 live on ClinicalTrials.gov.

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