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NCT05718817 · ClinicalTrials.gov record · last posted 2026-08-10

An Open-label Study of XEN1101 in Epilepsy

Name: An Open-label Study of XEN1101 in Epilepsy — clinical trial record (NCT05718817)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: X-TOLE4

StatusEnrolling by Invitation

PhasePhase 3

SponsorXenon Pharmaceuticals Inc.

Started2023-04-25

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

Protocol amendment history 3 changes detected by DataLookout

2026-05-15

Trial sites expanded: 146 → 149 locations

2026-04-14

Primary completion pushed: 2028-07 → 2033-04

2026-04-14

Completion pushed: 2028-09 → 2033-06

Trial Details

NCT Number	NCT05718817
Lead Sponsor	Xenon Pharmaceuticals Inc. Collaborators: Worldwide Clinical Trials
Conditions	Focal Epilepsy, Tonic-Clonic Seizures
Enrollment	880 participants
Start Date	2023-04-25
Primary Completion	2033-04 (estimated)
Study Completion	2033-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-10