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A Study of SGT-212 Gene Therapy in Friedreich's Ataxia

Study acronym: FALCON
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 18 words Site details revised at 1 of 3 sites Show 1 more changeShow less
    • Site details revised at 1 of 3 sites
  2. Site details revised at 1 of 3 sitesv9
  3. Re-verified, no change to tracked fieldsv8
  4. Site details revised at 1 of 3 sitesv7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 2 to 3v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  4. Start date: Oct 1, 2025 to Oct 22, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase 1b, first in-human, open-label, dose-finding study investigating the safety and tolerability of SGT-212 in participants with Friedreich's ataxia (FA). It will be delivered via dual intradentate nucleus (IDN) and intravenous (IV) administration to participants with FA. All participants will receive SGT-212 and will be enrolled in the study for approximately 5 years.
Trial Details
NCT Number NCT07180355
Lead Sponsor Solid Biosciences Inc.
Conditions Friedreich's Ataxia (FA)
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov