A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Launched by XENON PHARMACEUTICALS INC. · Nov 6, 2022
Trial Information
Current as of September 12, 2025
Recruiting
Keywords
ClinConnect Summary
The X-TOLE2 Phase 3 clinical trial is testing a new medication called XEN1101 to see how well it helps people with focal-onset seizures, which are a type of seizure that starts in one specific area of the brain. This study is comparing XEN1101 to a placebo (a sugar pill that has no active ingredients) to find out if the medication is safe and effective for managing these seizures. The trial is currently looking for participants aged 65 to 74 who have been diagnosed with focal epilepsy for at least two years and have tried at least two other seizure medications without achieving complete seizure control.
To take part in this trial, participants need to be able to keep a record of their seizures and must be on a stable dose of other seizure medications for at least a month before joining. Those who have had certain types of seizures or serious health issues in the past may not be eligible. If someone decides to participate, they will be closely monitored throughout the study and will have the chance to contribute to important research that could improve treatment for others with similar conditions.
Gender
ALL
Eligibility criteria
- 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.
About Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals Inc. is a biotechnology company focused on developing innovative therapeutics for the treatment of rare genetic disorders and other serious medical conditions. Leveraging its proprietary drug discovery platform, Xenon specializes in identifying and advancing novel drug candidates that target specific genetic pathways. The company is committed to addressing unmet medical needs through rigorous clinical research and development, with a robust pipeline aimed at delivering effective solutions for patients. Through collaboration with leading research institutions and a dedicated team of scientists, Xenon aims to transform the landscape of precision medicine and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
New York, New York, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
East Lansing, Michigan, United States
Westmead, New South Wales, Australia
Madrid, Spain
Chicago, Illinois, United States
Phoenix, Arizona, United States
Kansas City, Kansas, United States
Syracuse, New York, United States
Sacramento, California, United States
Baltimore, Maryland, United States
Philadelphia, Pennsylvania, United States
London, Ontario, Canada
Little Rock, Arkansas, United States
Madrid, Spain
Worcester, Massachusetts, United States
Tampa, Florida, United States
Oxford, United Kingdom
Hyattsville, Maryland, United States
Madrid, Spain
Madrid, Spain
Houston, Texas, United States
Leeds, United Kingdom
Dundee, United Kingdom
Sydney, New South Wales, Australia
Bethesda, Maryland, United States
Tübingen, Germany
Toledo, Ohio, United States
Valencia, Spain
Hamilton, New Zealand
Milwaukee, Wisconsin, United States
Lexington, Kentucky, United States
Worcester, Massachusetts, United States
Akron, Ohio, United States
Bonn, Germany
Berlin, Germany
Winston Salem, North Carolina, United States
Suwanee, Georgia, United States
Roma, Italy
Port Charlotte, Florida, United States
Scarborough, Maine, United States
Bronx, New York, United States
Tucson, Arizona, United States
Lexington, Kentucky, United States
Salford, United Kingdom
Phoenix, Arizona, United States
Virginia Beach, Virginia, United States
Saint Louis, Missouri, United States
Honolulu, Hawaii, United States
Pisa, Italy
Birmingham, United Kingdom
Blagoevgrad, Bulgaria
Katowice, Poland
Cardiff, United Kingdom
Winston Salem, North Carolina, United States
New York, New York, United States
Portland, Oregon, United States
Atlanta, Georgia, United States
Melbourne, Australia
San Antonio, Texas, United States
Auckland, New Zealand
Birmingham, United Kingdom
Burnsville, Minnesota, United States
Bydgoszcz, Poland
Orlando, Florida, United States
Marburg, Germany
Boise, Idaho, United States
Mobile, Alabama, United States
Valladolid, Spain
Málaga, Spain
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Lublin, Poland
Salford, United Kingdom
Ann Arbor, Michigan, United States
Hackensack, New Jersey, United States
Buenos Aires, Argentina
Radeberg, Germany
Pensacola, Florida, United States
Buffalo, New York, United States
Austin, Texas, United States
Sydney, New South Wales, Australia
Nowa Sól, Poland
Los Angeles, California, United States
San Francisco, California, United States
Lexington, Kentucky, United States
Roanoke, Virginia, United States
Seattle, Washington, United States
Brisbane, Queensland, Australia
Kogarah, Australia
Melbourne, Australia
Lethbridge, Alberta, Canada
Raleigh, North Carolina, United States
Porto, Portugal
Aurora, Colorado, United States
Grand Rapids, Michigan, United States
New York, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Fitzroy, Melbourne, Australia
Camperdown, New South Wales, Australia
Heidelberg, Victoria, Australia
Sofia, Bulgaria
Montréal, Quebec, Canada
Bologna, Italy
Rome, Italy
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Dundee, United Kingdom
El Paso, Texas, United States
Sacramento, California, United States
Coral Gables, Florida, United States
Weston, Florida, United States
Indianapolis, Indiana, United States
Portland, Maine, United States
Nashua, New Hampshire, United States
New York, New York, United States
Houston, Texas, United States
Melbourne, Victoria, Australia
Bielefeld, Germany
Frankfurt, Germany
Munich, Germany
Niederstotzingen, Germany
Ulm, Germany
Wakefield, West Yorkshire, United Kingdom
London, United Kingdom
London, United Kingdom
Buenos Aires, Argentina
Buenos Aires, Argentina
Mexico City, Mexico
Miami, Florida, United States
Pescara, Italy
Frieburg, Germany
Tucumán, Argentina
Prague, Czechia
Tbilisi, Georgia
Tbilisi, Georgia
Freiburg Im Breisgau, Germany
Riga, Latvia
Riga, Latvia
Warszawa, Poland
Dublin, Ireland
Sacramento, California, United States
San Francisco, California, United States
Scarborough, Maine, United States
New York, New York, United States
Raleigh, North Carolina, United States
Brisbane, Queensland, Australia
Radeberg, Germany
Ulm, Germany
Pescara, Italy
Rome, Italy
London, United Kingdom
Salford, United Kingdom
Clinton, Maryland, United States
Porto, Portugal
Saint Louis, Missouri, United States
Caba, Argentina
Córdoba, Argentina
Buenos Aires, Argentina
Santiago, Chile
Viña Del Mar, Chile
Sinaloa, Mexico
Santa Maria Da Feira, Portugal
Buenos Aires, Argentina
Patients applied
Trial Officials
Medical Director
Study Director
Xenon Pharmaceuticals Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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