A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Recruiting · NCT05716100 · Interventional (participants receive a specific treatment) · Lead sponsor: Xenon Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboXEN1101
What this trial is about
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). 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.
- Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
- Able to keep accurate seizure diaries
Exclusion criteria
- Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- 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.
- History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Where it is running
60 locations listed across 15 US states.
- Clinical Trials, Inc. - Little Rock, Arkansas, United States
- Rancho Research Institute - Downey, California, United States
- University of California Los Angeles (UCLA) - Los Angeles, California, United States
- University of California Irvine Health - Orange, California, United States
- Panhandle Research and Medical Clinic - Gulf Breeze, Florida, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Consultants in Epilepsy and Neurology, PLLC - Boise, Idaho, United States
- Southern Illinois University School of Medicine - Springfield, Illinois, United States
- Mid-Atlantic Epilepsy and Sleep Center - Bethesda, Maryland, United States
- 9D University Health Center - Detroit, Michigan, United States
- Northeast Regional Epilepsy Group - Hackensack, New Jersey, United States
- Five Towns Neuroscience Research - Woodmere, New York, United States
- Duke University Clinic - Durham, North Carolina, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- OhioHealth - Columbus, Ohio, United States
- Providence Neurological Specialities - Portland, Oregon, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Austin Epilepsy Care Center - Austin, Texas, United States
- University of Utah Clinical Neurosciences Center - Salt Lake City, Utah, United States
- Universitätsklinikum Aachen - Aachen, Germany
- Ospedali Riuniti di Ancona - Ancona, Italy
- Hospital Universitario Cruces - Barakaldo, Spain
- Università degli studi di Bari Aldo Moro - Bari, Italy
- Grupo Medico Camino - Benito Juárez, Mexico
- Krankenhaus Mara gGmbH - Bielefeld, Germany
- Hopital Neurologique Pierre Wertheimer - Bron, France
- Cliniques Universitaires Saint-Luc (UCL) - Brussels, Belgium
- Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika - Budapest, Hungary
- Hospital Ramos Mejia - Buenos Aires, Argentina
- Hospital De Alta Complejidad en Red el Cruce - Buenos Aires, Argentina
- Policlinico Lomas - Buenos Aires, Argentina
- Instituto de Neurologia Cognitiva (INECO) - Buenos Aires, Argentina
- Hospital Italiano - Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires - Buenos Aires, Argentina
- STAT Resarch S.A. - Buenos Aires, Argentina
- CENyR Centro de Especialidades Neurologicas y Rehabilitacion - C.a.b.a., Argentina
- FLENI - C.a.b.a., Argentina
- Centro Hospitalar Universitário de Coimbra - CHUC - Coimbra, Portugal
- Hospital Córdoba - Córdoba, Argentina
- University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main - Frankfurt, Germany
- COPERNICUS Podmiot Leczniczy - Gdansk, Poland
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Hospital da Senhora da Oliveira - Guimarães, Portugal
- Kempenhaeghe - Heeze, Netherlands
- EUC Hradec Kralove Clinic - Hradec Králové, Czechia
- University Hospital Innsbruck - Innsbruck, Austria
- Hadassah Medical Center - Jerusalem, Israel
- Kuopio University Hospital - Kuopio, Finland
- Centre Hospitalier Universitaire de Lille (CHU de Lille) - Lille, France
- Centro Hospitalar de Lisboa Norte - Lisbon, Portugal
- Centro Hospitalar Lisboa Ocidental - Lisbon, Portugal
- NZOZ Neuromed M. i M. Nastaj Sp. P. - Lublin, Poland
- Hospital Unversitario Ramon y Cajal - Madrid, Spain
- Hospital Clínico San Carlos - Madrid, Spain
- Hospital universitario Fundación Jiménez Díaz - Madrid, Spain
- Royal Melbourne Hospital - Melbourne, Australia
- Human Science Research Trials - Mexico City, Mexico
- Axis Heilsa S. de R.L. de C.V. Althian - Monterrey, Mexico
- Twoja Przychodnia Nowosolskie Centrum Medyczne - Nowa Sól, Poland
- University Hospital Center Osijek - Osijek, Croatia
Showing 60 of 95 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →