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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ENROLLING_BY_INVITATION
PHASE3
880 participants
INTERVENTIONAL
2023-04-25
2028-09-30
Brief Summary
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Detailed Description
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Following enrollment into X-TOLE4, subjects will undergo a treatment period of up to 3 years, during which there will be a visit at 2-, 4-, and 13-weeks post-entry, with subsequent visits occurring at 13-week intervals during the first year, and then at 26-week intervals (with a telephone call in between) until dosing is completed.
Subjects will be initially assigned to XEN1101 as follows:
* 25 mg QD for subjects aged ≥18 years
* For subjects aged ≥12 and \<18 years
* 15 mg QD for those
* who weigh \<45 kg at the start of the X-TOLE4 study
* who weighed \<45 kg during the X-ACKT study
* who weighed ≥45 kg at randomization in the X-ACKT study and had dose reduction(s) for intolerability
* 25 mg QD for all others
Subjects will be instructed to orally take XEN1101 once daily (QD) with an evening meal. Subjects will be expected to keep a daily seizure eDiary with a minimum of 80% compliance for the duration of the extension study (reporting on ≥80% of days between visits).
Upon completion of dosing at the end of the treatment period, there will be an 8-week follow up period.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XEN1101 15 or 25 mg/day
XEN1101 15 or 25 mg/day
XEN1101
XEN1101 capsules
Interventions
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XEN1101
XEN1101 capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must have successfully completed the double-blind treatment period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.
3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
4. Subject is able to keep accurate seizure diaries.
Exclusion Criteria
2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.
12 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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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
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
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
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
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
Countries
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Other Identifiers
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2022-502282-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
XPF-010-304
Identifier Type: -
Identifier Source: org_study_id