A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
NCT ID: NCT05667142
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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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2023-02-14
2027-06-30
Brief Summary
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Detailed Description
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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.
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
2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
3. 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.
4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
6. Subject is able to keep accurate seizure diaries.
Exclusion Criteria
2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
3. Subject has a history of non-epileptic psychogenic seizures.
4. Subject has a concomitant diagnosis of focal-onset seizures (FOS).
5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
6. Subject has 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.
7. Subject has history of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to Visit 1.
8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, obsessive-compulsive disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:
a. History or presence of long QT syndrome; QTcF \>450 msec at baseline; family history of sudden death of unknown cause.
10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.
The criteria to be eligible for randomization are:
1. During the last 56 days of the baseline period that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization.
2. Seizure diary was completed a minimum of 80% of all days (ie, ≥45 days) during the last 56 days of the baseline period that preceded randomization as evidence of adequate compliance.
3. Subject did not change dose of, stop, or initiate any new ASM(s) during the baseline period and plans on maintaining a stable dose of ASM(s) during the DBP.
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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University of Alabama - Strada Patient Care Center, Neurology
Mobile, Alabama, United States
Xenoscience
Phoenix, Arizona, United States
University of Arizona - Health Science Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Brain Science Research Institute
Los Angeles, California, United States
University of California, Irvine - Health Neurology Services
Orange, California, United States
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)
Sacramento, California, United States
University of Colorado Anschutz Medical Campus
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 and Medical Clinic
Pensacola, Florida, United States
Medsol Clinical Research Center Harbor Professional Centre
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
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Georgia Neurology & Sleep Medicine Associates
Suwanee, Georgia, United States
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
Honolulu, Hawaii, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States
University of Kentucky Albert B. Chandler Hospital (UK Healthcare)
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Medstar Georgetown University Hospital
Clinton, Maryland, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Michigan State University Department of Neurology
East Lansing, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Saint Louis University Medical School
St Louis, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Dent Neurosciences Research Facility
Amherst, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Five Towns Neurology
Woodmere, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Summa Health Clinical Research Center
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UPMC Comprehensive Epilepsy Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
ANESC Research
El Paso, Texas, United States
UTHealth Science Center at Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, United States
University of Washington, Regional Epilepsy Center at Harborview Medical Center
Seattle, Washington, United States
Advocate Aurora Research institute, St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Hospital General de Agudos J.M. Ramos Mejia
Buenos Aires, , Argentina
STAT Research S.A.
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
Sanatorio del Sur S.A
San Miguel de Tucumán, , Argentina
Southern Neurology
Kogarah, New South Wales, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, VC, Australia
Austin Health Pharmacy Clinical Trials
Heidelberg, Victoria, Australia
St Vincent's Hospital Melbourne, Clinical Neurosciences
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, , Australia
University Hospital Innsbruck
Innsbruck, , Austria
Universitaetsklinik fuer Kinder
Linz, , Austria
Universitätsklinik für Neurologie
Salzburg, , Austria
Universitätsklinik für Neurologie, Medizinische Universität Wien
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Multiprofile hospital for active treatment Puls AD
Blagoevgrad, , Bulgaria
MHATNP 'Sveti Naum' EAD
Sofia, , Bulgaria
First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel
Sofia, , Bulgaria
Center for Neurologic Research
Lethbridge, Alberta, Canada
Children and Women's Health Centre of BC (BC Children's Hospital)
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
Montreal, Quebec, Canada
Centro de investigación Clinica UC-CICUC
Santiago, , Chile
Clinical Hospital Center Osijek
Osijek, , Croatia
Clinical Hospital Center Rijeka
Rijeka, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol
Prague, , Czechia
CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique
Lille, , France
Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Lyon, , France
Hôpital Fondation A. de Rothschild
Paris, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Universitätsklinikum Aachen
Aachen, , Germany
Vivantes Humboldt Klinikum
Berlin, , Germany
Bethel Epilepsy Centre
Bielefeld, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Epilepsiezentrum im Neuozentrum
Freiburg im Breisgau, , Germany
Philipps-Universität Marburg
Marburg, , Germany
Klinikum der Universität München
München, , Germany
Epilepsiezentrum Kleinwachau gemeinnützige GmbH
Radeberg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Hadassah University Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Ancona, , Italy
Università Degli Studi Gabriele d'Annunzio Di Chieti
Chieti, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedalo Pediatrico Bambino Gesu
Roma, , Italy
Policlinico Umberto I
Roma, , Italy
Grupo Medico Camino SC
Mexico City, , Mexico
Human Science Research Trials S. de R.L. de C.V.
Mexico City, , Mexico
Neurociencias Estudios Clínicos S.C
Sinaloa, , Mexico
Kempenhaeghe
Heeze, , Netherlands
Centrum Medyczne Neuromed
Bydgoszcz, , Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, , Poland
Novo-Med Zielinski I Wspolnicy Sp. J.
Katowice, , Poland
NZOZ Neuromed M. i M.
Lublin, , Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, , Poland
Centro Hospitalar Universitário de Coimbra (CHUC)
Coimbra, , Portugal
Hospital da Senhora da Oliveira
Guimarães, , Portugal
Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz
Lisbon, , Portugal
Centre Hospitalar Universitario de Lisboa Norte (CHULN)
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, , Portugal
Centro Hospitalar Universitário de Santo António
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, , Portugal
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Clinico Viña del Mar
Valparaíso, , Spain
University Hospital of Wales
Cardiff, Wales, United Kingdom
Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
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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Central Contacts
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Other Identifiers
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2022-502286-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
XPF-010-303
Identifier Type: -
Identifier Source: org_study_id