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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Study acronym: X-CEED
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 28 → 44 locationsv10
  2. Study sites revised (28)v9 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 27 to 28v8
  4. Study sites: 26 to 27v7
  5. Study sites: 18 to 26v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 17 to 18v5
  2. Study sites: 13 to 17v4
  3. Study sites: 9 to 13v3
  4. Study sites: 5 to 9 Secondary endpoints reordered · Eligibility criteria shortened, about 5 wordsv2 Show 2 more changesShow less
    • Secondary endpoints reordered
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
Trial Details
NCT Number NCT07172516
Lead Sponsor Xenon Pharmaceuticals Inc.
Conditions Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov