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A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor 7 versions Re-verified since Mar 14, 2025, no change to tracked fieldsv23-v29
  2. Minor Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 130
    v22
  3. Minor 6 versions Re-verified since Jun 19, 2024, no change to tracked fieldsv16-v21
  4. Minor Eligibility criteria shortened, about 6 words
    • Secondary endpoint revised
    • Study description expanded, about 3 words
    v15
  5. Minor 11 versions Re-verified since Apr 6, 2023, no change to tracked fieldsv4-v14
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Nov 1, 2022 to Dec 8, 2022
    • Site contacts updated at 13 of 14 sites
    v3
  2. Minor Study sites: 0 to 14v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.
Trial Details
NCT Number NCT05515536
Lead Sponsor PTC Therapeutics
Conditions
(from sponsor)
Friedreich Ataxia
Related terms Friedreich Ataxia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov