A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
NCT ID: NCT05716100
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2023-05-09
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XEN1101 25 mg/day
XEN1101 25 mg/day
XEN1101
XEN1101 Capsules
XEN1101 15 mg/day
XEN1101 15 mg/day
XEN1101
XEN1101 Capsules
Placebo
Placebo
Placebo
Placebo Capsules
Interventions
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XEN1101
XEN1101 Capsules
Placebo
Placebo Capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
* Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
* Able to keep accurate seizure diaries
Exclusion Criteria
* History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-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 period preceding Visit 1 where the individual seizures cannot be counted.
* History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
18 Years
ALL
No
Sponsors
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Worldwide Clinical Trials
OTHER
Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Xenon Medical Director
Role: STUDY_DIRECTOR
Xenon Pharmaceuticals Inc.
Locations
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Rancho Research Institute
Downey, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
University of California Irvine Health
Orange, California, United States
Panhandle Research and Medical Clinic
Gulf Breeze, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
9D University Health Center
Detroit, Michigan, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Five Towns Neuroscience Research
Woodmere, New York, United States
Duke University Clinic
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States
Hospital Ramos Mejia
Buenos Aires, , Argentina
Hospital De Alta Complejidad en Red el Cruce
Buenos Aires, , Argentina
Policlinico Lomas
Buenos Aires, , Argentina
Instituto de Neurologia Cognitiva (INECO)
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
STAT Resarch S.A.
Buenos Aires, , Argentina
CENyR Centro de Especialidades Neurologicas y Rehabilitacion
C.a.b.a., , Argentina
FLENI
C.a.b.a., , Argentina
Hospital Córdoba
Córdoba, , Argentina
Sanatori del Sur S.A.
San Miguel de Tucumán, , Argentina
Westmead Hospital
Westmead, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
University Hospital Innsbruck
Innsbruck, , Austria
Universitätsklinik für Neurologie
Salzburg, , Austria
Medical University of Vienna
Vienna, , Austria
Cliniques Universitaires Saint-Luc (UCL)
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
MHATNPsy Sveti Naum EAD
Sofia, , Bulgaria
Medical center OPHTHA-NEURO
Sofia, , Bulgaria
Clinica Universidad de Los Andes
Santiago, , Chile
Centro de Investigacion Clinica UC
Santiago, , Chile
CINSAN
Santiago, , Chile
Hospital Clínico Viña del Mar
Viña del Mar, , Chile
University Hospital Center Osijek
Osijek, , Croatia
Clinical Hospital Center Rijeka, Klinika za Neurologiju
Rijeka, , Croatia
Poliklinika Bonifarm
Zagreb, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Poliklinika LF MEDICAL
Zagreb, , Croatia
EUC Hradec Kralove Clinic
Hradec Králové, , Czechia
Nemocnicni lekarna FN Motol / Motol University Hospital
Prague, , Czechia
Forbeli s.r.o.
Prague, , Czechia
Kuopio University Hospital
Kuopio, , Finland
Hopital Neurologique Pierre Wertheimer
Bron, , France
Centre Hospitalier Universitaire de Lille (CHU de Lille)
Lille, , France
Hôpital de la Pitié Salpêtrière
Paris, , France
Hôpital Fondation A. de Rothschild
Paris, , France
Chu de Rennes Hôpital Pontchaillou
Rennes, , France
Hôpital de Hautepierre
Strasbourg, , France
Universitätsklinikum Aachen
Aachen, , Germany
Krankenhaus Mara gGmbH
Bielefeld, , Germany
University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main
Frankfurt, , Germany
Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika
Budapest, , Hungary
Hadassah Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedali Riuniti di Ancona
Ancona, , Italy
Università degli studi di Bari Aldo Moro
Bari, , Italy
Grupo Medico Camino
Benito Juárez, , Mexico
Human Science Research Trials
Mexico City, , Mexico
Axis Heilsa S. de R.L. de C.V. Althian
Monterrey, , Mexico
Neurocencias Esudios Clinicos S.C.
Sinaloa, , Mexico
Kempenhaeghe
Heeze, , Netherlands
COPERNICUS Podmiot Leczniczy
Gdansk, , Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, , Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Centro Hospitalar Universitário de Coimbra - CHUC
Coimbra, , Portugal
Hospital da Senhora da Oliveira
Guimarães, , Portugal
Centro Hospitalar de Lisboa Norte
Lisbon, , Portugal
Centro Hospitalar Lisboa Ocidental
Lisbon, , Portugal
Centro Hospitalar Universitário de Santo António
Porto, , Portugal
Hospital Pedro Hispano
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, , Portugal
ULS de Trás-os-Montes e Alto Douro
Vila Real, , Portugal
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Unversitario Ramon y Cajal
Madrid, , Spain
Hospital universitario Fundación Jiménez Díaz
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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XPF-010-302
Identifier Type: -
Identifier Source: org_study_id
2022-502281-25-00
Identifier Type: CTIS
Identifier Source: secondary_id