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FA Clinical Outcome Measures

Study acronym: FA-COMS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study description revised
    • Collaborators reordered
    v18
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study description revised
    • Site details revised at 14 of 14 sites
    v17
  3. Site details revised at 4 of 14 sitesv16
  4. Lead sponsor: Children's Hospital of Philadelphia to Friedreich's Ataxia Research Alliance
    • Site details revised at 5 of 14 sites
    • Collaborators revised (2)
    v15
  5. Site contacts updated at 1 of 14 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Site contacts updated at 1 of 14 sitesv13
  2. Site contacts updated at 3 of 14 sitesv12
  3. Enrollment target: 1500 to 2000
    • Study description revised
    • Site details revised at 1 of 14 sites
    v11
  4. Study sites: 12 to 14v10
  5. Site contacts updated at 1 of 12 sitesv9
  6. Site contacts updated at 3 of 12 sitesv8
  7. Site contacts updated at 1 of 12 sitesv7
  8. Site contacts updated at 1 of 12 sitesv6
  9. Study sites: 9 to 12v5
  10. Site contacts updated at 1 of 9 sitesv4
  11. Site contacts updated at 1 of 9 sitesv3
  12. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter natural history study aims to expand the network of clinical research centers in FA, and to provide a framework for facilitating therapeutic interventions. In addition, this study will lead to the development of valid yet sensitive clinical measures crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support genetic modifier studies, biomarker studies, and frataxin protein level assessments by building a sample repository. This natural history study is no longer recruiting under this protocol NCT03090789 but remains actively recruiting under the harmonized study (UNIFAI) NCT06016946.
Trial Details
NCT Number NCT03090789
Lead Sponsor Friedreich's Ataxia Research Alliance
Collaborators: University of Rochester, Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Friedreich Ataxia, Neuro-Degenerative Disease
Related terms Friedreich Ataxia
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov