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Study identifier: NCT05716100 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Focal Onset Seizures  ·  Sponsor: Xenon Pharmaceuticals Inc.

PhasePhase 3
Planned participants360
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xenon Medical Affairs  ·  1-604-484-3300  ·  XenonCares@xenon-pharma.com

Always discuss trial participation with your own doctor first.

Locations (95)

Clinical Trials, Inc.Little Rock, Arkansas, United StatesRecruiting
Rancho Research InstituteDowney, California, United StatesRecruiting
University of California Los Angeles (UCLA)Los Angeles, California, United StatesRecruiting
University of California Irvine HealthOrange, California, United StatesRecruiting
Panhandle Research and Medical ClinicGulf Breeze, Florida, United StatesRecruiting
Mayo Clinic FloridaJacksonville, Florida, United StatesRecruiting
Consultants in Epilepsy and Neurology, PLLCBoise, Idaho, United StatesRecruiting
Southern Illinois University School of MedicineSpringfield, Illinois, United StatesRecruiting
Mid-Atlantic Epilepsy and Sleep CenterBethesda, Maryland, United StatesRecruiting
9D University Health CenterDetroit, Michigan, United StatesRecruiting
Northeast Regional Epilepsy GroupHackensack, New Jersey, United StatesRecruiting
Five Towns Neuroscience ResearchWoodmere, New York, United StatesWithdrawn

+ 83 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05716100