Clinical Trial

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

Study acronym: X-NOVA3
Recruiting Phase 3
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Summary
X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
Protocol Amendment History 2 changes
notable Trial sites expanded: 44 -> 48 locations 2026-08-04
notable Trial sites expanded: 35 -> 42 locations 2026-04-09
Trial Details
NCT Number NCT07076407
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Major Depressive Disorder
Enrollment 450 participants
Start Date 2025-07-08
Primary Completion 2027-05 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-03