Vatiquinone for Friedreich's Ataxia

(PROVE-FA Trial)

Not yet recruiting at 8 trial locations
PA
Overseen ByPatient Advocacy
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: PTC Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to confirm the treatment effects of vatiquinone on the key measures of FA disease progression.

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Friedreich's Ataxia confirmed by genetic testing, who can walk (even if limited), have a certain range of disease severity, and are able to avoid specific medications and supplements during the study.

Inclusion Criteria

I meet the main requirements for this study.
I am able to walk and move around on my own.
I scored the maximum on E4, E5, and E3b of the mFARS test at screening and baseline.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Vatiquinone

Trial Overview

The study is testing vatiquinone to see if it can slow down or improve symptoms of Friedreich's Ataxia over time. All participants receive the medication, and their progress will be closely monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: VatiquinoneExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PTC Therapeutics

Lead Sponsor

Trials
75
Recruited
6,300+

Dr. Matthew B. Klein

PTC Therapeutics

Chief Executive Officer since 2023

BA from the University of Pennsylvania, MD from Yale University School of Medicine, MS in Epidemiology from the University of Washington School of Public Health

Dr. Stuart W. Peltz

PTC Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School