At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 65 enrolled
Drug / intervention
RT001 +1 moredrug
Likely dose
RT001 960 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Controlled, Phase 2/3 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia
In Brief
A Phase 3 clinical trial evaluating RT001 and Placebo for Friedreich's Ataxia. Completed, enrolled 65 participants across 6 sites.
Detailed Summary
The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of RT001 in subjects with Friedreich's Ataxia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionAug 2021
TodayJul 2026
First PostedSep 25, 2019
Enrollment StartOct 30, 2019
Primary CompletionAug 23, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.8 years ago
Interventions
RT001drug
RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.
Placebodrug
The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.