A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
NCT ID: NCT05614063
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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ACTIVE_NOT_RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2022-11-18
2026-02-28
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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Medical Director
Role: STUDY_DIRECTOR
Xenon Pharmaceuticals Inc.
Locations
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Strada Patient Care Center
Mobile, Alabama, United States
Xenoscience
Phoenix, Arizona, United States
University of Arizona, Health Sciences Center
Tucson, Arizona, United States
Clinical Trials, Inc
Little Rock, Arkansas, United States
Brain Science Research Institute
Los Angeles, California, United States
University of California, David Clinical & Translational Science Center Clinical Research (CCRC)
Sacramento, California, United States
Anschutz Health Sciences
Aurora, Colorado, United States
Floridian Community Research Center
Coral Gables, Florida, United States
Serenity Research
Miami, Florida, United States
Research Institute of Orlando, LLC
Orlando, Florida, United States
Panhandle Research & Medical Clinic
Pensacola, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
Encore Medical Research of Weston, LLC
Weston, Florida, United States
Emory Brain Health Center
Atlanta, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Consultants in Epilepsy and Neurology
Boise, Idaho, United States
Indiana University, IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States
University of Kentucky, Dept. of Neurology
Lexington, Kentucky, United States
MaineHealth Neurology - Scarborough
Scarborough, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
MedStar Health Research Institute
Clinton, Maryland, United States
Medstar Health Research Institute
Hyattsville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Cornwell Health
Grand Rapids, Michigan, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, United States
Saint Louis University Medical School - Neurosciences Clinical Research Unit
St Louis, Missouri, United States
Washington University, St. Louis
St Louis, Missouri, United States
Northeast Epilepsy Group
Hackensack, New Jersey, United States
Dent Neurosciences Research Center
Buffalo, New York, United States
NYU Comprehensive Epilepsy Center (CEC)
New York, New York, United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Duke Neurology
Durham, North Carolina, United States
Meridian Clinical Research, LLC
Raleigh, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Summa Health
Akron, Ohio, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Austin Epilepsy Care Center (AECC)
Austin, Texas, United States
ANESC Research
El Paso, Texas, United States
UT Physicians Epilepsy Clinic
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
Carilion Clinic - Neurology
Roanoke, Virginia, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, United States
University of Washington Main Hospital
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
INECO and Favoloro Fundation
Buenos Aires, , Argentina
Hospital General de Agudos J.M. Ramos Mejia
Buenos Aires, , Argentina
Hospital De Alta Complejidad en Red el Cruce Nestor Kirchner - SAMIC
Buenos Aires, , Argentina
STAT Research S.A.
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
CENyR
Caba, , Argentina
Hospital Córdoba
Córdoba, , Argentina
Sanatorio del Sur S.A.
San Miguel de Tucumán, , Argentina
St Vincent's Hospital Melbourne
Fitzroy, Melbourne, Australia
The Royal Melbourne Hospital
Melbourne, Melbourne, Australia
Royal Prince Alfred Hospital (RAPH)
Camperdown, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Southern Neurology
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The University of Queensland (UQ) - Mater Research Institute (MRI)
Brisbane, Queensland, Australia
Austin Health Pharmacy Clinical Trials
Heidelberg, Victoria, Australia
The Alfred Hospital (Alfred Health)
Melbourne, Victoria, Australia
MHAT Puls AD
Blagoevgrad, , Bulgaria
Center For Neurologic Research
Lethbridge, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Quebec, Canada
Centro de investigación Clinica UC
Santiago, , Chile
Hospital Clínico Vina del Mar
Viña del Mar, , Chile
FORBELI s.r.o., Neurologicka ambulance
Prague, , Czechia
American Hospital Network LLC
Tbilisi, , Georgia
Institute of Neurology and Neuropsychology
Tbilisi, , Georgia
Epilepsy Center Bethel
Bielefeld, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Epilepsiezentrum Frankfurt Rhein-Main
Frankfurt, , Germany
University Medical Center Freiburg
Freiburg im Breisgau, , Germany
Philipps-Universität Marburg
Marburg, , Germany
LMU Munich, Department of Neurology
Munich, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm
Ulm, , Germany
Beaumont Hospital
Dublin, , Ireland
Istituto delle Scienze Neurologiche di Bologna
Bologna, , Italy
Università Degli Studi Gabriele d'Annunzio Di Chieti
Pescara, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, , Italy
Pauls Stradina Clinical university hospital
Riga, , Latvia
Riga East University Hospital
Riga, , Latvia
Human Science Research Trials S. de R.L. de C.V.
Mexico City, , Mexico
Neurocencias Esudios Clinicos SC
Sinaloa, , Mexico
University of Auckland
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Centrum Medyczne Neuromed
Bydgoszcz, , Poland
NZOZ Novo-Med
Katowice, , Poland
Twoja Przychodnia NCM
Nowa Sól, , Poland
Neurosphera Sp. z o.o.
Warsaw, , Poland
Unidade Local de Saúde de São João
Porto, , Portugal
Hospital Pedro Hispano
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, , Portugal
Unitat d'Assaigs Clínics. Servei de Farmàcia
Barcelona, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Hospital Vithas La Milagrosa
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
IIS-Fundacion Jimenez Diaz/Farmacia
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional De Malaga
Málaga, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Clínico Universitario Valladolid
Valladolid, , Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
St. George's Hospital NHS Foundation Trust
London, , United Kingdom
Royal London Hospital for Integrated Medicine
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Northern Care Alliance NHS Foundation Trust, Salford Care Organisation
Salford, , United Kingdom
Countries
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Other Identifiers
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2022-502000-73-00
Identifier Type: CTIS
Identifier Source: secondary_id
XPF-010-301
Identifier Type: -
Identifier Source: org_study_id