Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05127226 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

HALOS: A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Ascending Doses of ION582 in Participants With Angelman Syndrome

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 70 to confirmed 71 · Study description shortened, about 70 words · Site details revised at 11 of 11 sitesv23 Show 3 more changesShow less
    • Enrollment target: estimated 70 to confirmed 71
    • Study description shortened, about 70 words
    • Site details revised at 11 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 2 of 11 sitesv22
  3. Study description expanded, about 70 wordsv21 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 11 sitesv20
  5. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 51 to 70 · Study description shortened, about 11 words · Site details revised at 11 of 11 sites · 2 morev19 Show 5 more changesShow less
    • Enrollment target: 51 to 70
    • Study description shortened, about 11 words
    • Site details revised at 11 of 11 sites
    • Study arms: 9 to 10
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 17 earlier versionsHide 17 earlier versions
  1. Re-verified, no change to tracked fieldsv18
  2. Collaborators shortened, about 1 wordv17 See this version in full on ClinicalTrials.gov ↗
  3. Primary and study completion dates: Jan 2025 to Mar 2029 Study description expanded, about 24 words · Study arms: 7 to 9v16 Show 2 more changesShow less
    • Study description expanded, about 24 words
    • Study arms: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 44 to confirmed 51 · Site details revised at 11 of 11 sitesv15 Show 2 more changesShow less
    • Enrollment target: estimated 44 to confirmed 51
    • Site details revised at 11 of 11 sites
  5. Study sites: 10 to 11v14
  6. Study sites: 9 to 10v13
  7. Study sites: 8 to 9v12
  8. Primary completion date: Jul 2023 to Jan 2025 Study sites: 7 to 8 · Completion date: Dec 2023 to Jan 2025 · Secondary endpoints: details revised at 4 of 4 entries · 3 morev11 Show 6 more changesShow less
    • Study sites: 7 to 8
    • Completion date: Dec 2023 to Jan 2025
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 37 words
    • Study arms: 5 to 7
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 6 to 7v10
  10. Study sites: 5 to 6v9
  11. Study sites: 4 to 5v8
  12. Study sites: 2 to 4v7
  13. Study sites: 1 to 2v6
  14. Site contact updatedv5
  15. Site contact updatedv4
  16. Start date changed from estimate of Dec 2021 to Dec 22, 2021v3
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Nov 2021 to Dec 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Nov 2021 to Dec 2021
  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 tolerability of ascending doses of ION582 administered intrathecally in participants with Angelman syndrome.
Trial Details
NCT Number NCT05127226
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Angelman Syndrome
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov