An Open-label Study of XEN1101 in Epilepsy

Enrolling by invitation · Phase 3

Conditions studied: Focal Epilepsy, Tonic-Clonic Seizures

In brief

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.

Key facts

Study ID

NCT05718817

Run by

Xenon Pharmaceuticals Inc.

People needed

880

Starts

2023-04-25

Expected to finish

2033-06-01

Last updated by the study team

2026-07-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• Subject is able to keep accurate seizure diaries.

You may not qualify if…

• Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.
• 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.
• 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.

Where it is running

• University of Arizona - Health Sciences — Tucson, Arizona, United States
• Clinical Trials, Inc — Little Rock, Arkansas, United States
• Brain Science Research Institute — Los Angeles, California, United States
• UC Irvine Health — Orange, California, United States
• University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC) — Sacramento, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Serenity Research Center, LLC — Miami, Florida, United States
• Research Institute of Orlando, LLC — Orlando, Florida, United States
• Panhandle Research & Medical Clinic — Pensacola, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Encore Medical Research of Weston, LLC — Weston, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Consultants in Epilepsy and Neurology — Boise, Idaho, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Bluegrass Epilepsy Research, LLC — Lexington, Kentucky, United States
• Kentucky Clinic — Lexington, Kentucky, United States
• MMP Neurology — Scarborough, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• UMass Chan Medical School — Worcester, Massachusetts, United States
• University of Michigan Hospitals — Ann Arbor, Michigan, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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