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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Study acronym: X-TOLE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Sep 24, 2024 Primary endpoint revised · Secondary endpoints revised (2)v12 Show 2 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints: 2 to 1 Secondary endpoints revised (2) · Publications: details revised at 1 of 1 entryv11 Show 2 more changesShow less
    • Secondary endpoints revised (2)
    • Publications: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Oct 2026 to Oct 2028 Study description shortened, about 2 wordsv10 Show 1 more changeShow less
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv9
  5. Enrollment target: estimated 300 to confirmed 325 Completion date: Oct 2024 to Oct 2026 · Study description revised · Collaborator revisedv8 Show 3 more changesShow less
    • Completion date: Oct 2024 to Oct 2026
    • Study description revised
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 82 to 95 · Primary completion date changed from estimate of Jun 2021 to Sep 2, 2021 · Completion date: Jun 2022 to Oct 2024 · 1 morev6 Show 4 more changesShow less
    • Study sites: 82 to 95
    • Primary completion date changed from estimate of Jun 2021 to Sep 2, 2021
    • Completion date: Jun 2022 to Oct 2024
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jul 2020 to Jun 2021 Completion date: Jul 2020 to Jun 2022v5 Show 1 more changeShow less
    • Completion date: Jul 2020 to Jun 2022
  4. Primary endpoints revised (2) Study sites: 50 to 82 · Eligibility criteria expanded, about 117 words · Secondary endpoints revised (2) · 1 morev4 Show 4 more changesShow less
    • Study sites: 50 to 82
    • Eligibility criteria expanded, about 117 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 37 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 2 to 50v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jan 2019 to Jan 30, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 2019 to Jan 30, 2019
  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 XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).
Trial Details
NCT Number NCT03796962
Lead Sponsor Xenon Pharmaceuticals Inc.
Collaborators: Novotech Health Holdings Pte. Ltd.
Conditions Focal Epilepsy
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov