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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: 02 May 2026

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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

  • 20 Apr 2026 According to a Xenon Pharmaceuticals media release, company presented positive data from the Phase 3 X-TOLE study highlighting the efficacy and safety of azetukalner in focal onset seizures (FOS) at the American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026 in Chicago, Illinois.
  • 20 Apr 2026 Results presented in the Xenon Pharmaceuticals media release.
  • 07 Apr 2026 According to a Xenon Pharmaceuticals media release, data from this trial will be presented at the upcoming American Academy of Neurology (AAN) Annual Meeting.

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