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An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 15 → 20 locationsv8
  2. Trial sites expanded: 12 → 15 locationsv7
  3. Study sites: 10 to 12v6
  4. Study sites: 7 to 10v5
  5. Study sites: 4 to 7v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 3 to 4v3
  2. Study sites: 2 to 3 Start date changed from estimate of Oct 2025 to Oct 30, 2025v2 Show 1 more changeShow less
    • Start date changed from estimate of Oct 2025 to Oct 30, 2025
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.
Trial Details
NCT Number NCT07217860
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov