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A Study to Evaluate the Safety and Efficacy of Zilganersen (ION373) in Patients With Alexander Disease (AxD)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Sep 2029 to Jul 2034 Study description expanded, about 12 wordsv36 Show 1 more changeShow less
    • Study description expanded, about 12 words

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  2. Re-verified, no change to tracked fieldsv35
  3. Primary completion date changed from estimate of Sep 2025 to Aug 22, 2025v34
  4. Re-verified, no change to tracked fieldsv33
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 73 to confirmed 54v32 Show 1 more changeShow less
    • Enrollment target: estimated 73 to confirmed 54
Show 30 earlier versionsHide 30 earlier versions
  1. 3 versions Re-verified since Sep 23, 2024, no change to tracked fieldsv29-v31
  2. Study Status, Study Descriptionv28
  3. Trial status: Recruiting to Enrolling by Invitation Primary completion date: Mar 2025 to Sep 2025 · Completion date: Mar 2029 to Sep 2029 · Secondary endpoints: details revised at 12 of 15 entries · 3 morev27 Show 6 more changesShow less
    • Primary completion date: Mar 2025 to Sep 2025
    • Completion date: Mar 2029 to Sep 2029
    • Secondary endpoints: details revised at 12 of 15 entries
    • Study description expanded, about 16 words
    • Site details revised at 13 of 13 sites
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 14 to 13v26
  5. Interventions: ION373 (Drug), Placebo (Drug) to Placebo (Drug), zilganersen (Drug) Study description expanded, about 1 wordv25 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv24
  7. Primary completion date: Feb 2024 to Mar 2025 Completion date: Nov 2025 to Mar 2029 · Study description expanded, about 41 wordsv23 Show 2 more changesShow less
    • Completion date: Nov 2025 to Mar 2029
    • Study description expanded, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 15 to 14v22
  9. Study sites: 17 to 15v21
  10. Enrollment target: 58 to 73 Study sites: 16 to 17 · Eligibility criteria expanded, about 24 words · Secondary endpoints: 16 to 15 · 2 morev20 Show 5 more changesShow less
    • Study sites: 16 to 17
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: 16 to 15
    • Primary endpoint revised
    • Study description expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites revised (16)v19 See this version in full on ClinicalTrials.gov ↗
  12. Study sites: 15 to 16v18
  13. Study sites revised (15)v17 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (15)v16 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 7 to 15v15
  16. Study sites: 9 to 7v14
  17. Study sites: 8 to 9v13
  18. Study sites revised (8)v12 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 9 to 8v11
  20. Site contacts updated at 1 of 9 sitesv10
  21. Study sites: 8 to 9v9
  22. Re-verified, no change to tracked fieldsv8
  23. Study description expanded, about 34 words Study sites revised (8)v7 Show 1 more changeShow less
    • Study sites revised (8)

    See this version in full on ClinicalTrials.gov ↗

  24. Start date: May 2021 to Jun 1, 2021 Study sites revised (8)v6 Show 1 more changeShow less
    • Study sites revised (8)

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  25. Study sites: 7 to 8v5
  26. Site contacts updated at 1 of 7 sitesv4
  27. Study sites: 2 to 7 Start date: Apr 2021 to May 2021v3 Show 1 more changeShow less
    • Start date: Apr 2021 to May 2021
  28. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  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 purpose of this study is to evaluate the safety and efficacy of zilganersen (ION373) in improving or stabilizing gross motor function across the full range of affected domains in patients with AxD.
Trial Details
NCT Number NCT04849741
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Alexander Disease
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov