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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Sponsor: Xenon Pharmaceuticals Inc.
Summary
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
325
Start Date
2019-01-30
Completion Date
2028-10
Last Updated
2024-09-24
Healthy Volunteers
No
Conditions
Interventions
XEN1101
Oral dose
Locations (95)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Strada Patient Care Center
Mobile, Alabama, United States
Xenoscience, Inc.
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Altman Clinical Translational Research Institute (ACTRI)
La Jolla, California, United States
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
San Francisco, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Don Clinical Research Center
Miami, Florida, United States
The Neurology Research Group, LLC.
Miami, Florida, United States
Research Institute of Orlando, LLC
Orlando, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Georgia Neurology and Sleep Medicine Associate
Suwanee, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Boston Neuro Research Center
South Dartmouth, Massachusetts, United States
Minneapolis Clinic of Neurology, Ltd.
Golden Valley, Minnesota, United States
Minnesota Epilepsy Group, P. A.
Saint Paul, Minnesota, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, United States
Northeast Regional Epilepsy Group
Morristown, New Jersey, United States
Dent Neurosciences Research Center
Amherst, New York, United States
NYU Langone Medical Center/NYU School of Medicine
New York, New York, United States
Northwell Health - Lenox Hill
New York, New York, United States
SUNY Upstate Medical University Institute for Human Performance
Syracuse, New York, United States
Five Towns Neuroscience Research
Woodmere, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
UC Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Providence Neurological Specialties East
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States
Vanderbilt Epilepsy Clinic
Nashville, Tennessee, United States
Austin Epilepsy Care Center
Austin, Texas, United States
James W. Aston Ambulatory Care Center
Dallas, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah Health Clinical Neurosciences Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Neurology Clinic
Roanoke, Virginia, United States
Winchester Neurological Consultants
Winchester, Virginia, United States
UW Medicine Valle Medical Center
Renton, Washington, United States
University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center
Seattle, Washington, United States
Children's and Women's Health Centre of British Columbia (BC Children's Hospital)
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
University Health Network-Toronto Western Hospital
Toronto, Ontario, Canada
LLC Arensia Exploratory Medicine
Tbilisi, Georgia
Epilepsiezentrum Berlin-Brandenburg
Berlin, Germany
Bethel Epilepsy Centre
Bielefeld, Germany
Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie
Bonn, Germany
Universitatsklinikym Frankfurt
Frankfurt, Germany
Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum
Freiburg im Breisgau, Germany
University Hospital Munster (UKM)
Münster, Germany
Klinikum Osnabruck
Osnabrück, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, Germany
University of Tubingen-Dept. of Neurology and Epileptology
Tübingen, Germany
IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital
Bologna, Italy
Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro
Catanzaro, Italy
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Italy
IRCCS Istituto Neurologico Nazionale C. Mondino
Pavia, Italy
Azienda Ospedaliera Universita' Pisana
Pisa, Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria
Reggio Calabria, Italy
Policlinico di Roma Umberto I
Roma, Italy
PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine
Chisinau, Moldova
Hospital Virgen Macarena
Seville, Andalusia, Spain
Centro de Neurologia Avanzada
Seville, Andalusia, Spain
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain
Clínica Universidad Navarra
Pamplona, Navarre, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Vithas La Salud
Granada, Spain
Hospital U. Ramón y Cajal
Madrid, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital U. Clínico San Carlos
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Hospital Clínico Universitario Valladolid
Valladolid, Spain
Medical Center of Limited Liability Company "Harmoniya Krasy"
Kyiv, Ukraine
Institute of Neurological Sciences
Glasgow, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom