(+) Epicatechin to Treat Friedreich's Ataxia

Phase 2 Completed 10 enrolled Ralitza Gavrilova Cardero Therapeutics, Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2016-09
Primary completion: 2018-12-30
Completion: 2018-12-30

Outcome

Missed primary endpoint

registry analysis (superiority test); (+)-Epicatechin; p = 0.336; Wilcoxon (Mann-Whitney) NCT02660112 ↗

paper without statistically significant improvement in primary neurological outcomes. PMID 32677106 ↗

Publications

Qureshi MY, Patterson MC, Clark V, Johnson JN, Moutvic MA, Driscoll SW, Kemppainen JL, Huston J 3rd, Anderson JR, Badley AD, Tebben PJ, Wackel P, Oglesbee D, Glockner J, Schreiner G, Dugar S, Touchette JC, Gavrilova RH. Safety and efficacy of (+)-epicatechin in subjects with Friedreich's ataxia: A phase II, open-label, prospective study. J Inherit Metab Dis. 2021 Mar;44(2):502-514. doi: 10.1002/jimd.12285. Epub 2020 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	(-)-Epicatechin	Unknown	75 mg	Oral
Subject	(-)-Epicatechin	Unknown	150 mg	Oral