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Enrolling by invitationPhase 3

Long-term study of XEN1101 for epilepsy with seizures

Tests XEN1101 long term in people aged 12 or older with epilepsy.

Plain-language title generated from the registry record
Registry title: An Open-label Study of XEN1101 in Epilepsy

Key facts

Where
Akron, Ann Arbor, Aurora, Austin, Baltimore, Bethesda, Boise, Boston, Buffalo, Burnsville, Charlotte, Cleveland, Columbus, Detroit, Durham, East Lansing, El Paso, Grand Rapids, Hackensack, Honolulu, Indianapolis, Jacksonville, Kansas City, Lexington, Little Rock, Los Angeles, Miami, Milwaukee, Nashville, New York, Orange, Orlando, Pensacola, Philadelphia, Phoenix, Portland, Raleigh, Roanoke, Sacramento, Salt Lake City, San Antonio, Scarborough, Seattle, St Louis, Syracuse, Tampa, The Bronx, Tucson, Virginia Beach, Weston, and Worcester, United StatesSee the 54 sites
Phase
Phase 3

Where in United States

  • Summa HealthAkron, United StatesNo longer taking part
  • University of Michigan HospitalsAnn Arbor, United StatesNo longer taking part
  • University of Colorado Hospital - Anschutz Outpatient PavilionAurora, United StatesNo longer taking part
  • Austin Epilepsy Care CenterAustin, United StatesNo longer taking part
  • University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
  • Mid-Atlantic Epilepsy and Sleep CenterBethesda, United StatesNo longer taking part
  • Consultants in Epilepsy and NeurologyBoise, United StatesNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesNo longer taking part
  • Dent Neurosciences Research CenterBuffalo, United StatesNo longer taking part
  • Minneapolis Clinic of NeurologyBurnsville, United StatesNo longer taking part
  • OnSite Clinical SolutionsCharlotte, United StatesNo longer taking part
  • Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
  • The Ohio State University Brain and Spine HospitalColumbus, United StatesNo longer taking part
  • Wayne State UniversityDetroit, United StatesNo longer taking part
  • Duke UniversityDurham, United StatesNo longer taking part
  • Michigan State UniversityEast Lansing, United StatesNo longer taking part
  • ANESC ResearchEl Paso, United StatesNo longer taking part
  • Cornwell Health (Spectrum Health Hospitals)Grand Rapids, United StatesNo longer taking part
  • Northeast Epilepsy GroupHackensack, United StatesNo longer taking part
  • Hawaii Pacific NeuroscienceHonolulu, United StatesNo longer taking part
  • Indiana University School of MedicineIndianapolis, United StatesNo longer taking part
  • Mayo Clinic FloridaJacksonville, United StatesNo longer taking part
  • The University of Kansas Medical CenterKansas City, United StatesNo longer taking part
  • Bluegrass Epilepsy Research, LLCLexington, United StatesNo longer taking part
  • Kentucky ClinicLexington, United StatesNo longer taking part
  • Clinical Trials Inc.Little Rock, United StatesNo longer taking part
  • Brain Science Research InstituteLos Angeles, United StatesNo longer taking part
  • Serenity Research Center, LLCMiami, United StatesNo longer taking part
  • Aurora St. Luke's Medical CenterMilwaukee, United StatesNo longer taking part
  • Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
  • Mount Sinai HealthNew York, United StatesNo longer taking part
  • New York University Comprehensive Epilepsy CenterNew York, United StatesNo longer taking part
  • UC Irvine HealthOrange, United StatesNo longer taking part
  • Research Institute of Orlando LLCOrlando, United StatesNo longer taking part
  • Panhandle Research & Medical ClinicPensacola, United StatesNo longer taking part
  • Thomas Jefferson UniversityPhiladelphia, United StatesNo longer taking part
  • University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
  • XenosciencePhoenix, United StatesNo longer taking part
  • Providence Neurological SpecialitiesPortland, United StatesNo longer taking part
  • Meridian Clinical Research, LLCRaleigh, United StatesNo longer taking part
  • Carilion ClinicRoanoke, United StatesNo longer taking part
  • University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)Sacramento, United StatesNo longer taking part
  • University of Utah Clinical Neurosciences CenterSalt Lake City, United StatesNo longer taking part
  • UT Health San AntonioSan Antonio, United StatesNo longer taking part
  • MMP NeurologyScarborough, United StatesNo longer taking part
  • University of Washington Main HospitalSeattle, United StatesNo longer taking part
  • Saint Louis University Medical SchoolSt Louis, United StatesNo longer taking part
  • SUNY Upstate Medical UniversitySyracuse, United StatesNo longer taking part
  • University of South FloridaTampa, United StatesNo longer taking part
  • Montefiiore Medical CenterThe Bronx, United StatesNo longer taking part
  • University of Arizona - Health SciencesTucson, United StatesNo longer taking part
  • Sentara Neurology SpecialistsVirginia Beach, United StatesNo longer taking part
  • Encore Medical Research of Weston, LLCWeston, United StatesNo longer taking part
  • UMass Chan Medical SchoolWorcester, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Xenon Pharmaceuticals Inc.
Trial code
NCT05718817EU 2022-502282-24-00
Record updated
2 November 2026
Original description
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.Read full original descriptionShow less

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

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.

Inclusion: 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.

Exclusion: 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; 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 met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.

ClinicalTrials.gov NCT05718817 · EU CTIS 2022-502282-24-00