A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Focal Onset Seizures

In brief

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.

Key facts

Study ID

NCT05716100

Run by

Xenon Pharmaceuticals Inc.

People needed

360

Starts

2023-05-09

Expected to finish

2026-12-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• University Hospital Center Zagreb — Zagreb, Croatia (enrolling)
• Rancho Research Institute — Downey, California, United States (enrolling)
• Cliniques Universitaires Saint-Luc (UCL) — Brussels, Belgium (enrolling)
• Poliklinika Bonifarm — Zagreb, Croatia (enrolling)
• Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• University of California Irvine Health — Orange, California, United States (enrolling)
• University Hospital Innsbruck — Innsbruck, Austria (enrolling)
• Medical University of Vienna — Vienna, Austria (enrolling)
• Clinical Trials, Inc. — Little Rock, Arkansas, United States (enrolling)
• Duke University Clinic — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• OhioHealth — Columbus, Ohio, United States (enrolling)
• Providence Neurological Specialities — Portland, Oregon, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Austin Epilepsy Care Center — Austin, Texas, United States (enrolling)
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States (enrolling)
• 9D University Health Center — Detroit, Michigan, United States (enrolling)
• Panhandle Research and Medical Clinic — Gulf Breeze, Florida, United States (enrolling)
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States (enrolling)
• Universitätsklinik für Neurologie — Salzburg, Austria (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• University of California Los Angeles (UCLA) — Los Angeles, California, United States (enrolling)
• Poliklinika LF MEDICAL — Zagreb, Croatia (enrolling)

Full record on ClinicalTrials.gov

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