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ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 11 to 12 Eligibility criteria expanded, about 19 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 19 words
  2. Study sites: 10 to 11v14
  3. Study sites: 9 to 10v13
  4. Study sites: 8 to 9v12
  5. Study sites: 6 to 8v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: May 2026 to Sep 2027 Eligibility criteria shortened, about 65 words · Study description revisedv10 Show 2 more changesShow less
    • Eligibility criteria shortened, about 65 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 5 to 6v9
  3. Study sites: 4 to 5v8
  4. Study sites: 3 to 4v7
  5. Study sites: 2 to 3v6
  6. Study sites: 1 to 2v5
  7. Start date changed from estimate of Oct 2024 to Oct 21, 2024v4
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  9. Start date: Aug 2024 to Oct 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 ION440.
Trial Details
NCT Number NCT06430385
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov