A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Completed · Phase 3 · Has a placebo group

Conditions studied: Focal Onset Seizures

In brief

The X-TOLE2 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

NCT05614063

Run by

Xenon Pharmaceuticals Inc.

People needed

380

Starts

2022-11-18

Expected to finish

2026-02-03

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

• CENyR — Caba, Argentina
• Strada Patient Care Center — Mobile, Alabama, United States
• Xenoscience — Phoenix, Arizona, United States
• University of Arizona, Health Sciences Center — Tucson, Arizona, United States
• Clinical Trials, Inc — Little Rock, Arkansas, United States
• Brain Science Research Institute — Los Angeles, California, United States
• University of California, David Clinical & Translational Science Center Clinical Research (CCRC) — Sacramento, California, United States
• Anschutz Health Sciences — Aurora, Colorado, United States
• Serenity Research — Miami, Florida, United States
• Hospital Italiano — Buenos Aires, Argentina
• Research Institute of Orlando, LLC — Orlando, Florida, United States
• Panhandle Research & Medical Clinic — Pensacola, Florida, United States
• Medsol Clinical Research Center — 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
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Consultants in Epilepsy and Neurology — Boise, Idaho, United States
• Indiana University, IU Health Partners, Adult Neurology Clinic — Indianapolis, Indiana, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Bluegrass Epilepsy Research, LLC — Lexington, Kentucky, United States
• University of Kentucky, Dept. of Neurology — Lexington, Kentucky, United States
• MaineHealth Neurology - Scarborough — Scarborough, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Hospital Córdoba — Córdoba, Argentina

Full record on ClinicalTrials.gov

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