Clinical Trial

An Open-Label Study of Azetukalner in Major Depressive Disorder

Study acronym: X-NOVA-OLE
Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
Summary
X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
Protocol Amendment History 2 changes
notable Trial sites expanded: 63 -> 68 locations 2026-08-04
notable Trial sites expanded: 49 -> 63 locations 2026-06-02
Trial Details
NCT Number NCT06922110
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Major Depressive Disorder
Enrollment 460 participants
Start Date 2025-03-18
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-03