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An Open-label Study of XEN1101 in Epilepsy
Sponsor: Xenon Pharmaceuticals Inc.
Summary
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 3 years.
Official title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
880
Start Date
2023-04-25
Completion Date
2028-09
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
XEN1101
XEN1101 capsules
Locations (146)
Xenoscience
Phoenix, Arizona, United States
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
Wayne State University
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Cornwell Health (Spectrum Health Hospitals)
Grand Rapids, Michigan, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, United States
Saint Louis University Medical School
St Louis, Missouri, United States
Northeast Epilepsy Group
Hackensack, New Jersey, United States
Dent Neurosciences Research Center
Buffalo, New York, United States
New York University Comprehensive Epilepsy Center
New York, New York, United States
Mount Sinai Health
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiiore Medical Center
The Bronx, New York, United States
Onsite Clinical Solutions
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Meridian Clinical Research, LLC
Raleigh, North Carolina, United States
Summa Health
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Brain and Spine Hospital
Columbus, Ohio, United States
Providence Neurological Specialities
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Epilepsy Care Center
Austin, Texas, United States
ANESC Research
El Paso, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States
Carilion Clinic
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
Hospital General de Agudos "José M. Ramos Mejía"
Buenos Aires, Argentina
Asociacion Medica de Lomas de Zamora S.A. - Policlinicio Lomas
Buenos Aires, Argentina
STAT Research S.A.
Buenos Aires, Argentina
Centro de Psicología Médica San Martín de Tours SRL (CITES-INECO)
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
CENyR, Centro de Especialidades Neurologicas u Rehabilitacion
Buenos Aires, Argentina
FLENI (Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia)
Buenos Aires, Argentina
Hospital Córdoba
Córdoba, Argentina
Hospital De Alta Complejidad en Red El Cruce - Dr Nester Carlos Kirchner Servicio de Atencion Medica Integral Para la Communidad
San Juan Bautista, Argentina
Sanatorio del SUR S.A.
San Miguel de Tucumán, Argentina
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
St Vincent's Hospital Melbourne
Fitzroy, Australia
Austin Health Pharmacy Clinical Trials
Heidelberg, Australia
Southern Neurology
Kogarah, Australia
Alfred Hospital Neurology CT Dept of Neuroscience
Melbourne, Australia
The Royal Melbourne Hospital
Parkville, Australia
Mater Misericordiae Ltd South Brisbane
South Brisbane, Australia
Westmead Hospital Dept. of Neurology Epilepsy Unit
Westmead, Australia
University Hospital Innsbruck
Innsbruck, Austria
Universitatsklinik fur Neurologie, Medizinische Universitat Wien
Vienna, Austria
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Hospital for active treatmnt Puls AD Neurology Dpt
Blagoevgrad, Bulgaria
MHATNP St. Naum
Sofia, Bulgaria
Center for Neurologic Research
Lethbridge, Alberta, Canada
London Health Sciences Center
London, Ontario, Canada
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Canada
Centro de investigación Clinica UC
Santiago, Chile
Hospital Clinico Viña del Mar
Viña del Mar, Chile
Altavita Centar j.d.o.o.
Zagreb, Croatia
Poliklinika Bonifarm
Zagreb, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Motol University Hospital
Prague, Czechia
Forbeli s.r.o.
Prague, Czechia
Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Lyon, France
Hôpital Fondation Adolphe de Rothschild
Paris, France
Hôpitaux Universitaires Pitié Salpêtrière
Paris, France
CHU De Rennes - Hôpital Pontchaillou
Rennes, France
Hôpital de Hautepierre
Strasbourg, France
American Hospital Network LLC
Tbilisi, Georgia
Institute of Neurology and Neuropsychology
Tbilisi, Georgia
Universitätsklinikum Aachen
Aachen, Germany
Krankenhaus Mara gGmbH
Bielefeld, Germany
Universitätsklinikum, ZNN - Epilepsiezentrum Frankfurt Rhein-Main
Frankfurt, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
Philipps-Universität Marburg
Marburg, Germany
Klinikum der Universität München
München, Germany
Universitaets-Und Rehabilitations Ulm (RKU)
Ulm, Germany
Semmelweis Egyetem, Idegsebeszeti es Neurointervencios Klinika
Budapest, Hungary
Beaumont Hospital
Dublin, Ireland
Hadassah Medical Center (HMC)
Jerusalem, Israel
Kaplan Medical Center (KMC)
Rehovot, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS Istituto delle Scienze Neurologiche Bologna
Bologna, Italy
Universita' Degli Studi Gabriele d'Annunzio Di Chieti
Chieti, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, Italy
Human Science Research Trials
Mexico City, Mexico
Grupo Medico Camino SC
Mexico City, Mexico
Neurociencias Estudios Clínicos SC
Sinaloa, Mexico
University of Auckland
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Centrum Medyczne Neuromed
Bydgoszcz, Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland
NZOZ Neuromed M. i M.
Lublin, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, Poland
Neurosphera Sp z o.o.
Warsaw, Poland
Centro Hospitalar Universitário de Coimbra (CHUC)
Coimbra, Portugal
Hospital Senhora da Oliviera de Guimaraes
Guimarães, Portugal
Centro Hospitalar Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Portugal
Centro Hospitalar Universitario de Santo António, E.P.E
Porto, Portugal
Unidade Local de Saúde de São João
Porto, Portugal
Unidade Local Saúde Matosinhos
Porto, Portugal
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, Portugal
Hospital Universitario Cruces
Barakaldo, Spain
Vall d'Hebron Hospital
Barcelona, Spain
Hospital Vithas La Milagrosa
Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Regional De Malaga
Málaga, Spain
Hospital La Fe
Valencia, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
Cardiff and Vale UHB
Cardiff, Wales, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
St George's Hospital NHS Foundation Trust
London, United Kingdom
University College London
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)
Salford, United Kingdom