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Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects With Angelman Syndrome (AS)

Study acronym: Aspire
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jul 2026 to Jul 10, 2026v19
  2. 3 versions Re-verified since Nov 4, 2025, no change to tracked fieldsv16-v18
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 120 to confirmed 129 · Study sites: 31 to 28 · Study title expanded, about 2 wordsv15 Show 3 more changesShow less
    • Enrollment target: estimated 120 to confirmed 129
    • Study sites: 31 to 28
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (31)v14 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (31)v13 See this version in full on ClinicalTrials.gov ↗
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites revised (31)v12 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (31)v11 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 30 to 31v10
  4. Study sites: 29 to 30v9
  5. Study sites revised (29)v8 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 28 to 29v7
  7. Eligibility criteria shortened, about 77 words Secondary endpoints: 6 to 9 · Study sites revised (28)v6 Show 2 more changesShow less
    • Secondary endpoints: 6 to 9
    • Study sites revised (28)

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites revised (28)v5 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 29 to 28v4
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 29 · Start date changed from estimate of Dec 2024 to Dec 3, 2024v3 Show 2 more changesShow less
    • Study sites: 1 to 29
    • Start date changed from estimate of Dec 2024 to Dec 3, 2024
  11. Study sites: 0 to 1v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objective of this study is to evaluate the effect of GTX-102 in cognitive function in participants with deletion-type Angelman Syndrome (AS).
Trial Details
NCT Number NCT06617429
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Angelman Syndrome
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov