A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Start Date
2/14/2023
Completion Date
6/1/2027
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).
Detailed Description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in subjects diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 anti-seizure medications (ASMs). Eligible subjects will be randomly assigned 1:1 to XEN1101 or placebo: subjects aged ≥ 18 years will receive XEN1101 25 mg or placebo, and subjects aged ≥12 years and \<18 years will receive either XEN1101 15 mg, 25 mg, or placebo. Randomization will be stratified based on region, age group, and background use of CYP3A4-inducer ASMs. Eligible subjects will have up to 9.5 weeks durations to assess the baseline frequency of seizures, followed by a double-blind treatment period (DBP) where subjects will receive 12 weeks of blinded treatment. 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 enroll in a separate open-label-extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter an 8-week post-treatment follow-up period.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
XEN1101
Placebo
Conditions
Locations
University of Alabama - Strada Patient Care Center, Neurology
Mobile, Alabama 36604
United States
Xenoscience
Phoenix, Arizona 85004
United States
University of Arizona - Health Science Center
Tucson, Arizona 85724
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Brain Science Research Institute
Los Angeles, California 90025
United States
University of California, Irvine - Health Neurology Services
Orange, California 92868
United States
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)
Sacramento, California 95817
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Serenity Research Center, LLC
Miami, Florida 33176
United States
Research Institute of Orlando, LLC
Orlando, Florida 32806
United States
Panhandle Research and Medical Clinic
Pensacola, Florida 32503
United States
Medsol Clinical Research Center Harbor Professional Centre
Port Charlotte, Florida 33952
United States
University of South Florida
Tampa, Florida 33606
United States
Encore Medical Research of Weston, LLC
Weston, Florida 33331
United States
Emory Brain Health Center
Atlanta, Georgia 30329
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30342
United States
Georgia Neurology & Sleep Medicine Associates
Suwanee, Georgia 30024
United States
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, Hawaii 96817
United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho 83702
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62794
United States
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky 40504
United States
University of Kentucky Albert B. Chandler Hospital (UK Healthcare)
Lexington, Kentucky 40536
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
MedStar Franklin Square Medical Center
Baltimore, Maryland 21237
United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
United States
Medstar Georgetown University Hospital
Clinton, Maryland 20735
United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
United States
UMass Memorial Medical Center
Worcester, Massachusetts 01655
United States
University of Michigan Hospitals
Ann Arbor, Michigan 48109
United States
Wayne State University
Detroit, Michigan 48201
United States
Michigan State University Department of Neurology
East Lansing, Michigan 48824
United States
Spectrum Health
Grand Rapids, Michigan 49503
United States
Saint Louis University Medical School
St Louis, Missouri 14624
United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United States
Dent Neurosciences Research Facility
Amherst, New York 14226
United States
SUNY Upstate Medical University
Syracuse, New York 13201
United States
Five Towns Neurology
Woodmere, New York 11598
United States
Atrium Health
Charlotte, North Carolina 28203
United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina 28211
United States
Duke University Clinical Research
Durham, North Carolina 27710
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104
United States
Summa Health Clinical Research Center
Akron, Ohio 44304
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
The Ohio State University
Columbus, Ohio 43210
United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
UPMC Comprehensive Epilepsy Center
Pittsburgh, Pennsylvania 15213
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
ANESC Research
El Paso, Texas 79912
United States
UTHealth Science Center at Houston
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah 84132
United States
Sentara Neurology Specialists
Virginia Beach, Virginia 23456
United States
University of Washington, Regional Epilepsy Center at Harborview Medical Center
Seattle, Washington 98104
United States
Advocate Aurora Research institute, St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Hospital General de Agudos J.M. Ramos Mejia
Buenos Aires, 1221
Argentina
STAT Research S.A.
Buenos Aires, C1023AAB
Argentina
Hospital Italiano
Buenos Aires, C1181ACH
Argentina
Sanatorio del Sur S.A
San Miguel de Tucumán, 4000
Argentina
Southern Neurology
Kogarah, New South Wales 2217
Australia
Mater Misericordiae Ltd
South Brisbane, Queensland 4101
Australia
The Alfred Hospital
Melbourne, VC 3004
Australia
Austin Health Pharmacy Clinical Trials
Heidelberg, Victoria 3084
Australia
St Vincent's Hospital Melbourne, Clinical Neurosciences
Melbourne, Victoria 3065
Australia
The Royal Melbourne Hospital
Parkville, 3050
Australia
University Hospital Innsbruck
Innsbruck, 6020
Austria
Universitaetsklinik fuer Kinder
Linz, 4021
Austria
Universitätsklinik für Neurologie
Salzburg, 5020
Austria
Universitätsklinik für Neurologie, Medizinische Universität Wien
Vienna, 1090
Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Multiprofile hospital for active treatment Puls AD
Blagoevgrad, 2700
Bulgaria
MHATNP 'Sveti Naum' EAD
Sofia, 1113
Bulgaria
First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel
Sofia, 1142
Bulgaria
Center for Neurologic Research
Lethbridge, Alberta T1J 0N9
Canada
Children and Women's Health Centre of BC (BC Children's Hospital)
Vancouver, British Columbia V6H 3V4
Canada
London Health Sciences Center
London, Ontario N6A5A5
Canada
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
Centro de investigación Clinica UC-CICUC
Santiago,
Chile
Clinical Hospital Center Osijek
Osijek, 310 00
Croatia
Clinical Hospital Center Rijeka
Rijeka, 510 00
Croatia
University Hospital Center Zagreb
Zagreb, 100 00
Croatia
Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol
Prague, 150 06
Czechia
CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique
Lille, 59037
France
Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Lyon, 9003
France
Hôpital Fondation A. de Rothschild
Paris, 75019
France
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
France
Universitätsklinikum Aachen
Aachen, D-52074
Germany
Vivantes Humboldt Klinikum
Berlin, 13509
Germany
Bethel Epilepsy Centre
Bielefeld, 33617
Germany
Universitätsklinikum Frankfurt
Frankfurt, 60528
Germany
Epilepsiezentrum im Neuozentrum
Freiburg im Breisgau, 79106
Germany
Philipps-Universität Marburg
Marburg, 35043
Germany
Klinikum der Universität München
München, 81377
Germany
Epilepsiezentrum Kleinwachau gemeinnützige GmbH
Radeberg, 01454
Germany
Universitätsklinikum Tübingen
Tübingen, 72076
Germany
Universitätsklinikum Ulm
Ulm, 89081
Germany
Hadassah University Medical Center
Jerusalem, 9112001
Israel
The Chaim Sheba Medical Center
Ramat Gan, 6265601
Israel
Kaplan Medical Center
Rehovot, 7661041
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Ancona, 60126
Italy
Università Degli Studi Gabriele d'Annunzio Di Chieti
Chieti, 66100
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Ospedalo Pediatrico Bambino Gesu
Roma, 00165
Italy
Policlinico Umberto I
Roma, 185
Italy
Grupo Medico Camino SC
Mexico City, 03310
Mexico
Human Science Research Trials S. de R.L. de C.V.
Mexico City, 14050
Mexico
Neurociencias Estudios Clínicos S.C
Sinaloa, 80020
Mexico
Kempenhaeghe
Heeze, 5591BL VE
Netherlands
Centrum Medyczne Neuromed
Bydgoszcz, 85-163
Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, 80-803
Poland
Novo-Med Zielinski I Wspolnicy Sp. J.
Katowice, 40-584
Poland
NZOZ Neuromed M. i M.
Lublin, 20-064
Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, 67-100
Poland
Centro Hospitalar Universitário de Coimbra (CHUC)
Coimbra, 3000-075
Portugal
Hospital da Senhora da Oliveira
Guimarães, 4835-044
Portugal
Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz
Lisbon, 1349-019
Portugal
Centre Hospitalar Universitario de Lisboa Norte (CHULN)
Lisbon, 1649-035
Portugal
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, 4450-024
Portugal
Centro Hospitalar Universitário de Santo António
Porto, 4050-342
Portugal
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, 4520-211
Portugal
Hospital Universitario 12 de Octubre
Madrid, 280 41
Spain
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, 28010
Spain
Hospital Regional Universitario de Málaga
Málaga, 29010
Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Spain
Hospital Clinico Viña del Mar
Valparaíso, 2520612
Spain
University Hospital of Wales
Cardiff, Wales CF14 4XW
United Kingdom
Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire WF1 4DG
United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
United Kingdom
University College London Hospitals NHS Foundation Trust
London, WC1N 3BG
United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU
United Kingdom
Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)
Salford, M6 8HD
United Kingdom