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An Open-label Study of XEN1101 in Epilepsy

Study acronym: X-TOLE4
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 7 words Study description expanded, about 7 words · Site details revised at 10 of 152 sites Show 2 more changesShow less
    • Study description expanded, about 7 words
    • Site details revised at 10 of 152 sites
  2. Study sites: 151 to 152v24
  3. Re-verified, no change to tracked fieldsv23
  4. Study sites: 149 to 151v22
  5. Trial sites expanded: 146 → 149 locationsv21
  6. Primary completion pushed from Jul 2028 to Apr 2033 Completion pushed from Sep 2028 to Jun 2033 · Secondary endpoints: details revised at 5 of 5 entries · Study description revisedv20 Show 3 more changesShow less
    • Completion pushed from Sep 2028 to Jun 2033
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 145 to 146v19
  8. Study sites: 142 to 145v18
  9. Study sites: 139 to 142v17
  10. Study sites: 133 to 139v16
  11. Study sites: 126 to 133v15
  12. Study sites: 120 to 126v14
  13. Study sites: 114 to 120v13
  14. Study sites: 106 to 114v12
  15. Study sites: 97 to 106v11
  16. Study sites: 95 to 97v10
  17. Study sites: 89 to 95v9
  18. Study sites: 84 to 89v8
  19. Study sites: 74 to 84 Eligibility criteria expanded, about 5 words · Study description expanded, about 1 wordv7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 18 to 74 Eligibility criteria expanded, about 23 words · Study description expanded, about 47 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 15 to 18v5
  22. Primary completion date: Jun 2026 to Jul 2028 Study sites: 2 to 15 · Completion date: Jun 2027 to Sep 2028v4 Show 2 more changesShow less
    • Study sites: 2 to 15
    • Completion date: Jun 2027 to Sep 2028
  23. Study sites: 1 to 2v3
  24. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Apr 2023 to Apr 25, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2023 to Apr 25, 2023
  25. 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.
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.
Trial Details
NCT Number NCT05718817
Lead Sponsor Xenon Pharmaceuticals Inc.
Collaborators: Worldwide Clinical Trials
Conditions Focal Epilepsy, Tonic-Clonic Seizures
Enrollment 880 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov