NCT04577352Phase 2, phase 3Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-04-04Actual

Enrollment · participants146Actual

Source updated2026-04-13Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-04-08 · 1 field changed

Main study measure wording changed

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− Before

Measure: Change From Baseline in the ~~Modified Friedreich Ataxia Rating Scale (~~mFARS) Score at Week 72

+ After

Measure: Change From Baseline in the mFARS Score at Week 72 - Modified Intent-to-treat (mITT) Analysis Set Measure: Change From Baseline in the mFARS Score at Week 72 - Intent-to-treat (ITT) Analysis Set

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Study details

Conditions studied

Friedreich Ataxia

Treatments or interventions studied

VatiquinoneDrug
PlaceboDrug

Primary outcomes · main study measures

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measure: Change From Baseline in the mFARS Score at Week 72 - Modified Intent-to-treat (mITT) Analysis Set; description: mFARS is a 93-item scale; comprised of neurologic component of FARS. For each item, responses categorize the corresponding neurological finding, with a score ranging from 0 to 3, 4, or 5 with 0 being normal and higher numbers indicative of greater impairment. Total mFARS scores for each subscale: bulbar (0 to 5), upper limb coordination (0 to 36), lower limb coordination (0 to 16), and upright stability (0 to 36). mFARS total score was a composite score of all 4 subscales, ranging from 0 (normal) to 93 (greater impairment). A lower score = better neurological function. Missing data was imputed using pattern mix model multiple imputation. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated measures (MMRM).; timeFrame: Baseline, Week 72; measure: Change From Baseline in the mFARS Score at Week 72 - Intent-to-treat (ITT) Analysis Set; description: mFARS is a 93-item scale; comprised of neurologic component of FARS. For each item, responses categorize the corresponding neurological finding, with a score ranging from 0 to 3, 4, or 5 with 0 being normal and higher numbers indicative of greater impairment. Total mFARS scores for each subscale: bulbar (0 to 5), upper limb coordination (0 to 36), lower limb coordination (0 to 16), and upright stability (0 to 36). mFARS total score was a composite score of all 4 subscales, ranging from 0 (normal) to 93 (greater impairment). A lower score = better neurological function. Missing data was imputed using pattern mix model multiple imputation. LS mean and SE was calculated using MMRM.; timeFrame: Baseline, Week 72

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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