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

About

Brief Summary

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 in Study PTC743-NEU-003-FA (NCT04577352) or Study PTC743-NEU-005-FA.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • Participants with FA who completed and directly rolled over from a previous vatiquinone clinical study (PTC743-NEU-003-FA [that is, MOVE-FA] or PTC743-NEU-005-FA).
  • Males and females of childbearing potential must be willing to use an effective method of contraception (for example, implants, injectables, transdermal patches, combined oral contraceptives, barrier methods, and intrauterine devices) from the time consent is signed until 30 days after the last dose of study drug or Early Termination Visit.

Exclusion Criteria:

  • Current participation in any other interventional study
  • Pregnancy or breastfeeding

Join this Trial

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Study Stats
Protocol No.
22-001496
Category
Neurology
Principal Investigator
Contact
Aaron Fisher
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05515536
For detailed technical eligibility, visit ClinicalTrials.gov.