At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
Low dose cohort +1 moredrug
Likely dose
Low dose cohort 900 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 Study to Assess the Safety, Tolerability, and Pharmacokinetics of RT001 in Patients With Friedreich's Ataxia
In Brief
A Phase 2 clinical trial evaluating Low dose cohort and High dose cohort for Friedreich's Ataxia. Completed, enrolled 19 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionJun 2016
Study CompletionJul 2016
TodayJul 2026
First PostedMay 15, 2015
Enrollment StartAug 1, 2015
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.1 years ago
Interventions
Low dose cohortdrug
RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
High dose cohortdrug
RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.