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NCT05716100 · ClinicalTrials.gov record · last posted 2026-05-14

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

StatusRecruiting
PhasePhase 3
Started2023-05-09
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 18 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 18 times since 2023-02-06; most recent amendment 2026-05-12. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-07-25
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT05716100
Lead Sponsor Xenon Pharmaceuticals Inc.
Collaborators: Worldwide Clinical Trials
Conditions Focal Onset Seizures
Enrollment 360 participants
Start Date 2023-05-09
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-14