At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
(+)-Epicatechindrug
Likely dose
(+)-Epicatechin 25mgfrom 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 Phase II, Open Label Prospective Single Center Drug Study Evaluating the Safety and Efficacy of (+)-Epicatechin in Subjects With Friedreich's Ataxia
In Brief
A Phase 2 clinical trial evaluating (+)-Epicatechin for Friedreich's Ataxia. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesUnited States
CollaboratorsCardero Therapeutics, Inc.
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartSep 2016
Primary CompletionDec 2018
TodayJul 2026
First PostedJan 21, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.4 years ago
Interventions
(+)-Epicatechindrug
25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)