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

NCT04577352 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-04-13

Study results available
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Summary

The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale \[mFARS\]) and safety of vatiquinone in participants with Friedreich ataxia (FA).

Conditions

  • Friedreich Ataxia

Interventions

DRUG

Vatiquinone

Vatiquinone will be administered per dose and schedule specified in the arm.

DRUG

Placebo

Placebo will be administered per schedule specified in the arm.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-04-04
Completion
2023-10-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • New Zealand
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577352 on ClinicalTrials.gov