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An Open-Label Study of Azetukalner in Major Depressive Disorder

Study acronym: X-NOVA-OLE
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 68 → 71 locationsv7
  2. Trial sites expanded: 63 → 68 locationsv6
  3. Trial sites expanded: 49 → 63 locationsv5
  4. Study sites: 24 to 49v4
  5. Study sites: 12 to 24v3
  6. Study sites: 2 to 12v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06922110
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Major Depressive Disorder
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov