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Long-term Extension of GTX-102 in Angelman Syndrome

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Ultragenyx Pharmaceutical Inc

Record History

  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv13
  2. Primary endpoint(s) modified Eligibility criteria shortened, about 21 words · Secondary endpoints: 1 to 2v12 Show 2 more changesShow less
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since Jan 6, 2026, no change to tracked fieldsv10-v11
  4. Enrollment target: 75 to 255 Eligibility criteria expanded, about 91 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 91 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 23 sitesv7
  2. Study sites: 24 to 23v6
  3. Study description shortened, about 6 wordsv5 See this version in full on ClinicalTrials.gov ↗
  4. 2 versions Re-verified since Sep 13, 2024, no change to tracked fieldsv3-v4
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Aug 2024 to Jul 31, 2024v2 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2024 to Jul 31, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS)
Trial Details
NCT Number NCT06415344
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Angelman Syndrome
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov