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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Oct 2026 → Jan 2028
See other at-risk trials from Xenon Pharmaceuticals Inc.

Record History

  1. Primary completion pushed from Oct 2026 to Jan 2028 Trial sites expanded: 95 → 98 locations · Completion pushed from Dec 2026 to Mar 2028 · Eligibility criteria expanded, about 10 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 95 → 98 locations
    • Completion pushed from Dec 2026 to Mar 2028
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Study sites: 94 to 95v19
  3. Study sites: 89 to 94v18
  4. Study sites: 86 to 89v17
  5. Study sites: 84 to 86v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 74 to 84v15
  2. Study sites: 69 to 74v14
  3. Primary completion date: Aug 2025 to Oct 2026 Study sites: 67 to 69 · Completion date: Dec 2025 to Dec 2026v13 Show 2 more changesShow less
    • Study sites: 67 to 69
    • Completion date: Dec 2025 to Dec 2026
  4. Study sites: 66 to 67v12
  5. Study sites: 65 to 66v11
  6. Study sites: 62 to 65v10
  7. Study sites: 59 to 62v9
  8. Study sites: 58 to 59v8
  9. Study sites: 52 to 58v7
  10. Site details revised at 1 of 52 sitesv6
  11. Study sites: 29 to 52v5
  12. Study sites: 5 to 29v4
  13. Study sites: 2 to 5v3
  14. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 2023 to May 9, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2023 to May 9, 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Trial Details
NCT Number NCT05716100
Lead Sponsor Xenon Pharmaceuticals Inc.
Collaborators: Worldwide Clinical Trials
Conditions Focal Onset Seizures
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov