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Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2

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

Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 39
    • Site details revised at 16 of 16 sites
    v13
  2. Study sites: 12 to 16v12
  3. Study sites: 8 to 12v11
  4. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised at 1 of 8 sites
    v10
  5. Primary and study completion dates: Sep 2026 to Dec 2026v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 6 to 8v8
  2. Site details revised at 1 of 6 sitesv7
  3. Study sites: 4 to 6v6
  4. Study sites: 2 to 4
    • Start date changed from estimate of Jan 2025 to Dec 17, 2024
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2024 to Jan 2025
    • Study sites: 1 to 2
    v3
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adult participants with spinocerebellar ataxia type 2 (SCA2) who carry ≥33 cytosine, adenine, guanine (CAG) repeats in the ATXN2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose of ARO-ATXN2 or placebo and be evaluated for safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters.
Trial Details
NCT Number NCT06672445
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Spinocerebellar Ataxia Type 2
Related terms Spinocerebellar Ataxias
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov