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Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv11
  2. Study description shortened, about 1 wordv10 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 6 to 7v9
  4. Study sites: 5 to 6v8
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 5v6
  2. Study sites: 2 to 4v5
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 2024 to Apr 10, 2024v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2024 to Apr 10, 2024
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Dec 2023 to Mar 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the safety and tolerability of ION356.
Trial Details
NCT Number NCT06150716
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Pelizaeus-Merzbacher Disease
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov