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A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

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Trial Profile

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Jul 2025

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At a glance

  • Drugs Azetukalner (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms X-TOLE2
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 12 Jun 2025 Planned End Date changed from 1 Jun 2025 to 1 Feb 2026.
  • 12 Jun 2025 Planned primary completion date changed from 1 Apr 2025 to 1 Dec 2025.
  • 12 May 2025 According to a Xenon Pharmaceuticals media release, patient recruitment expected to complete in the next few months and first topline data readout anticipated in early 2026.

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