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REVEAL: A Phase 3 Study of Obudanersen (ION582) in Angelman Syndrome

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

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 158 to confirmed 156 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 7 of 9 entries · 2 more Show 5 more changesShow less
    • Enrollment target: estimated 158 to confirmed 156
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 7 of 9 entries
    • Study description revised
    • Site details revised at 41 of 41 sites
  2. Study sites: 42 to 41v32
  3. Interventions: ION582 (Drug), Placebo (Drug) to Placebo (Drug), obudanersen (Drug) Study description revised · Study title expanded, about 1 wordv31 Show 2 more changesShow less
    • Study description revised
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 40 to 42v30
  5. Study sites: 38 to 40v29
Show 27 earlier versionsHide 27 earlier versions
  1. Site details revised at 2 of 38 sitesv28
  2. Site details revised at 1 of 38 sitesv27
  3. Site details revised at 1 of 38 sitesv26
  4. Site details revised at 1 of 38 sitesv25
  5. Study sites: 37 to 38v24
  6. Site details revised at 1 of 37 sitesv23
  7. Study sites: 36 to 37v22
  8. Study sites: 28 to 36v21
  9. Study sites: 27 to 28v20
  10. Study sites: 24 to 27v19
  11. Study sites: 20 to 24v18
  12. Primary endpoint revised Enrollment target: 210 to 158 · Study sites: 18 to 20 · Eligibility criteria expanded, about 11 words · 3 morev17 Show 6 more changesShow less
    • Enrollment target: 210 to 158
    • Study sites: 18 to 20
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 67 words
    • Study arms: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 17 to 18v16
  14. Study sites: 16 to 17v15
  15. Study sites: 15 to 16v14
  16. Study sites: 14 to 15v13
  17. Study sites: 12 to 14v12
  18. Study sites: 16 to 12v11
  19. Study sites: 12 to 16v10
  20. Study sites: 9 to 12v9
  21. Study sites: 6 to 9v8
  22. Study sites: 4 to 6v7
  23. Study sites: 3 to 4v6
  24. Study sites: 2 to 3v5
  25. Study sites: 1 to 2v4
  26. Start date changed from estimate of May 2025 to Jun 10, 2025v3
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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 efficacy and safety of obudanersen in children and adults with Angelman syndrome caused by a deletion or mutation of the UBE3A gene.
Trial Details
NCT Number NCT06914609
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Angelman Syndrome
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov