Active — Not RecruitingPhase 3

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

United States130 participantsStarted 2022-12-08

Plain-language 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.

Who can participate

SexALL

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Inclusion Criteria: * Participants with FA who completed and directly rolled over from a previous vatiquinone clinical study. * 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

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Baseline up to 3 years

Trial details

NCT IDNCT05515536

SponsorPTC Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Friedreich Ataxia trials