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Clinical Trials in Ireland / NCT05718817
Enrolling by invitation Phase 3

An Open-label Study of XEN1101 in Epilepsy

NCT05718817 · tracked via the Priya Life Science Ireland tracker
Sponsor
Xenon Pharmaceuticals Inc.
Phase
Phase 3
Started
2023-04-25
Last updated
2026-09-11

Condition(s) studied

Focal EpilepsyTonic-Clonic Seizures

Investigational drug(s) / intervention(s)

XEN1101 →

XEN1101: XEN1101 capsules

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study. 2. Subject must have successfully completed the double-blind treatment period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study. 3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements. 4. Subject is able to keep accurate seizure diaries. Exclusion Criteria: 1. Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT. 2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol. 3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.

Primary outcome measure(s)

Trial sites (152)

FacilityCityRegionStatus
Xenoscience Phoenix Arizona
University of Arizona - Health Sciences Tucson Arizona
Clinical Trials, Inc Little Rock Arkansas
Brain Science Research Institute Los Angeles California
UC Irvine Health Orange California
University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC) Sacramento California
University of Colorado Hospital Anschutz Outpatient Pavilion Aurora Colorado
Mayo Clinic Florida Jacksonville Florida
Serenity Research Center, LLC Miami Florida
Research Institute of Orlando, LLC Orlando Florida
Panhandle Research & Medical Clinic Pensacola Florida
University of South Florida Tampa Florida
Encore Medical Research of Weston, LLC Weston Florida
Hawaii Pacific Neuroscience Honolulu Hawaii
Consultants in Epilepsy and Neurology Boise Idaho
Indiana University School of Medicine Indianapolis Indiana
The University of Kansas Medical Center Kansas City Kansas
Bluegrass Epilepsy Research, LLC Lexington Kentucky
Kentucky Clinic Lexington Kentucky
MMP Neurology Scarborough Maine
University of Maryland Medical Center Baltimore Maryland
Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland
Brigham and Women's Hospital Boston Massachusetts
UMass Chan Medical School Worcester Massachusetts
University of Michigan Hospitals Ann Arbor Michigan
Wayne State University Detroit Michigan
Michigan State University East Lansing Michigan
Cornwell Health (Spectrum Health Hospitals) Grand Rapids Michigan
Minneapolis Clinic of Neurology Burnsville Minnesota
Saint Louis University Medical School St Louis Missouri
Northeast Epilepsy Group Hackensack New Jersey
Dent Neurosciences Research Center Buffalo New York
New York University Comprehensive Epilepsy Center New York New York
Mount Sinai Health New York New York
SUNY Upstate Medical University Syracuse New York
Montefiiore Medical Center The Bronx New York
Onsite Clinical Solutions Charlotte North Carolina
Duke University Durham North Carolina
Meridian Clinical Research, LLC Raleigh North Carolina
Summa Health Akron Ohio

+ 112 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05718817 on ClinicalTrials.gov ↗ ← All trials in Ireland