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NCT03796962 · ClinicalTrials.gov record · last posted 2024-09-24

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Study acronym: X-TOLE
StatusActive, Not Recruiting
PhasePhase 2
Started2019-01-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

Amendment record 11 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 11 times since 2019-01-07; most recent amendment 2024-09-17. 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 ↗

2021-10-22
Status change Recruiting→Active, Not Recruitingv5
2019-02-06
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT03796962
Lead Sponsor Xenon Pharmaceuticals Inc.
Collaborators: Novotech Health Holdings Pte. Ltd.
Conditions Focal Epilepsy
Enrollment 325 participants
Start Date 2019-01-30
Primary Completion 2021-09-02 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2024-09-24