A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Last updated: April 28, 2025
Sponsor: Xenon Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

XEN1101

Clinical Study ID

NCT05614063
XPF-010-301
2022-502000-73-00
  • Ages > 18
  • All Genders

Study Summary

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be properly informed of the nature and risks of the study and give informed consentin writing, prior to entering the study

  • Diagnosis (≥2 years) of focal epilepsy according to the International League AgainstEpilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequatetrials of at least 2 ASMs, which were given (and tolerated) at adequate therapeuticdoses, without achieving sustained seizure freedom.

  • Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one monthprior to screening, during baseline, and throughout the duration of the DBP

  • Able to keep accurate seizure diaries

Exclusion

Exclusion Criteria:

  • Previously documented electroencephalogram which shows any pattern not consistentwith focal etiology of seizures.

  • History of focal aware non-motor seizures only, non-epileptic psychogenic seizure,primary generalized seizure, developmental and epileptic encephalopathy, includingLennox-Gastaut syndrome.

  • Seizures secondary to drug or alcohol use, ongoing infection, neoplasia,demyelinating disease, degenerative neurological disease, metabolic illness,progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.

  • History of status epilepticus or repetitive seizures within the 12-month periodpreceding Visit 1 where the individual seizures cannot be counted.

  • History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2years prior to enrollment.

  • Any medical condition or personal circumstance that, in the opinion of theinvestigator, exposes the subject to unacceptable risk by participating in the studyor prevents adherence to the protocol.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 18, 2022
Estimated Completion Date:
June 30, 2025

Study Description

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.

Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

Connect with a study center

  • Hospital General de Agudos J.M. Ramos Mejia

    Buenos Aires, 1221
    Argentina

    Active - Recruiting

  • STAT Research S.A.

    Buenos Aires, C1023AAB
    Argentina

    Active - Recruiting

  • CENyR

    Caba, C1424
    Argentina

    Active - Recruiting

  • Hospital Córdoba

    Córdoba, CP 5000
    Argentina

    Active - Recruiting

  • Sanatorio del Sur S.A.

    Tucumán, 4000
    Argentina

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Melbourne 3065
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital (RAPH)

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Sydney, New South Wales 2031
    Australia

    Active - Recruiting

  • Southern Neurology

    Sydney, New South Wales 2217
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • The University of Queensland (UQ)

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • The University of Queensland (UQ) - Mater Research Institute (MRI)

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Austin Health Pharmacy Clinical Trials

    Heidelberg, Victoria 3079
    Australia

    Active - Recruiting

  • The Alfred Hospital (Alfred Health)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Southern Neurology

    Kogarah, 2217
    Australia

    Site Not Available

  • Alfred Health

    Melbourne, 3004
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Melbourne, 3052
    Australia

    Active - Recruiting

  • MHAT Puls AD

    Blagoevgrad, 2700
    Bulgaria

    Active - Recruiting

  • First Multiprofile Hospital for Active Treatment

    Sofia, 1142
    Bulgaria

    Site Not Available

  • Center For Neurologic Research

    Lethbridge, Alberta T1J 0N9
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Le Centre Hospitalier de l'Universite' de Montreal (CHUM)

    Montréal, Quebec H2X3E4
    Canada

    Active - Recruiting

  • FORBELI s.r.o., Neurologicka ambulance

    Prague, 160-00
    Czechia

    Active - Recruiting

  • American Hospital Network LLC

    Tbilisi, 0121
    Georgia

    Active - Recruiting

  • Institute of Neurology and Neuropsychology

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • Vivantes Humboldt Klinikum

    Berlin, 13509
    Germany

    Active - Recruiting

  • Epilepsy Center Bethel

    Bielefeld, 33617
    Germany

    Active - Recruiting

  • Universitatsklinikum Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Epilepsiezentrum Frankfurt Rhein-Main

    Frankfurt, 60528
    Germany

    Active - Recruiting

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106
    Germany

    Active - Recruiting

  • University Medical Center Freiburg

    Frieburg, 79106
    Germany

    Site Not Available

  • Philipps-Universität Marburg

    Marburg, 35043
    Germany

    Active - Recruiting

  • LMU Munich, Department of Neurology

    Munich, 81277
    Germany

    Active - Recruiting

  • Universitaets-Und Rehabilitations Ulm RKU

    Niederstotzingen,
    Germany

    Site Not Available

  • Epilepsiezentrum Kleinwachau Gemeinnutzige eGmbH

    Radeberg, 01454
    Germany

    Active - Recruiting

  • Epilepsiezentrum Kleinwachau gGmbH

    Radeberg, 01454
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Universitaets-Und Rehabilitations Ulm RKU

    Ulm, 89081
    Germany

    Active - Recruiting

  • Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Beaumont Hospital

    Dublin, D09 YD60
    Ireland

    Active - Recruiting

  • Istituto delle Scienze Neurologiche di Bologna

    Bologna, 40139
    Italy

    Active - Recruiting

  • Università Degli Studi Gabriele d'Annunzio Di Chieti

    Pescara, 66100
    Italy

    Active - Recruiting

  • Università degli Studi "G. d'Annunzio" Chieti - Pescara

    Pescara, 66100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Rome, 00186
    Italy

    Active - Recruiting

  • Universita' La Sapienza di Roma

    Rome, 00186
    Italy

    Active - Recruiting

  • Pauls Stradina Clinical university hospital

    Riga, LV-1002
    Latvia

    Active - Recruiting

  • Riga East University Hospital

    Riga, LV-1024
    Latvia

    Active - Recruiting

  • University of Auckland

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Active - Recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163
    Poland

    Active - Recruiting

  • NZOZ Novo-Med

    Katowice, 40-650
    Poland

    Active - Recruiting

  • Clinical Best Solutions

    Lublin, 20-078
    Poland

    Site Not Available

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100
    Poland

    Active - Recruiting

  • Neurosphera Sp. z o.o.

    Warszawa, 02-829
    Poland

    Active - Recruiting

  • Hospital Pedro Hispano

    Porto, 4464-513
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de São João

    Porto, 4200-450
    Portugal

    Active - Recruiting

  • Unitat d'Assaigs Clínics. Servei de Farmàcia

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Ruber Internacional

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Vithas La Milagrosa

    Madrid, 28034
    Spain

    Active - Recruiting

  • IIS-Fundacion Jimenez Diaz/Farmacia

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Regional De Malaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Mid Yorkshire Hospitals NHS Trust

    Wakefield, West Yorkshire WF1 4DG
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham, B152TH
    United Kingdom

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B152GW
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF144XW
    United Kingdom

    Active - Recruiting

  • Clinical Trials

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Research Pharmacy

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • Royal London Hospital for Integrated Medicine

    London, WC1N 3HR
    United Kingdom

    Active - Recruiting

  • St. George's Hospital NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • Greater Manchester Neuroscience Centre

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • Northern Care Alliance NHS Foundation Trust, Salford Care Organisation

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • Strada Patient Care Center

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • St. Joseph's Hospital

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Xenoscience

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • University of Arizona, Health Sciences Center

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Clinical Trials, Inc

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Brain Science Research Institute

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • UC Davis Clinical and Translational Science Center Clinical Research

    Sacramento, California 95817
    United States

    Active - Recruiting

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California, David Clinical & Translational Science Center Clinical Research (CCRC)

    Sacramento, California 95817
    United States

    Active - Recruiting

  • CPMC Research Institute

    San Francisco, California 94107
    United States

    Active - Recruiting

  • California Pacific Medical Center (CPMC)

    San Francisco, California 94107
    United States

    Site Not Available

  • Anschutz Health Sciences

    Aurora, Colorado 80011
    United States

    Active - Recruiting

  • Floridian Community Research Center

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Serenity Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Research Institute of Orlando, LLC

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Panhandle Research & Medical Clinic

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Medsol Clinical Research Center

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Encore Medical Research of Weston, LLC

    Weston, Florida 33021
    United States

    Active - Recruiting

  • Emory Brain Health Center

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Georgia Neurology and Sleep Medicine Associates

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Consultants in Epilepsy and Neurology

    Boise, Idaho 83702
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University, IU Health Partners, Adult Neurology Clinic

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Bluegrass Epilepsy Research, LLC

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • UK HealthCare - Kentucky Neuroscience Institute (KNI)

    Lexington, Kentucky 40536-0284
    United States

    Active - Recruiting

  • University of Kentucky, Dept. of Neurology

    Lexington, Kentucky 40536-0284
    United States

    Active - Recruiting

  • MMC inpatient pharmacy

    Portland, Maine 04102
    United States

    Active - Recruiting

  • MMP Neurology

    Scarborough, Maine 04074
    United States

    Active - Recruiting

  • MaineHealth Neurology - Scarborough

    Scarborough, Maine 04074
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • MedStar Health Research Institute

    Clinton, Maryland 20735
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Hyattsville, Maryland 20782
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Cornwell Health

    Grand Rapids, Michigan 49506
    United States

    Active - Recruiting

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Saint Louis University Medical School - Neurosciences Clinical Research Unit

    Saint Louis, Missouri 63104
    United States

    Active - Recruiting

  • Washington University, St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Joseph's Hospital

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • Northeast Epilepsy Group

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467-2401
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center

    Buffalo, New York 14226
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Active - Recruiting

  • NYPH WCMC-Research Pharmacy

    New York, New York 11355
    United States

    Site Not Available

  • NYU Comprehensive Epilepsy Center (CEC)

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • Weill Cornell Medicine/ New York-Presbyterian Hospital

    New York, New York 10021
    United States

    Active - Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Duke Neurology

    Durham, North Carolina 27713
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Summa Health

    Akron, Ohio 44304
    United States

    Active - Recruiting

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Providence Brain & Spine Institute

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140-4105
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Austin Epilepsy Care Center (AECC)

    Austin, Texas 78758
    United States

    Active - Recruiting

  • ANESC Research

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • UT Physicians Epilepsy Clinic

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Carilion Clinic - Neurology

    Roanoke, Virginia 24013
    United States

    Active - Recruiting

  • Sentara Neurology Specialists

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • University of Washington Main Hospital

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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