Overview
A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2027-12-31
2027-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PTC Therapeutics
Criteria
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