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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs Azetukalner (Primary) ; Antiepileptic drugs
  • Indications Partial epilepsies; Seizures
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms X-TOLE
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 05 Dec 2025 According to a Xenon Pharmaceuticals media release, data from this trial will be presented at the American Epilepsy Society Annual Meeting (AES 2025), taking place December 5-9, 2025 in Atlanta, Georgia.
  • 03 Nov 2025 According to a Xenon Pharmaceuticals media release, the company plans to present new long-term safety and efficacy data from the ongoing X-TOLE open-label extension study of azetukalner in FOS, at the upcoming American Epilepsy Society (AES) 2025 meeting taking place December 5-9 in Atlanta.
  • 12 May 2025 According to a Xenon Pharmaceuticals media release, data from this study were presented at the American Academy of Neurology Annual Meeting (AAN).

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