NCT01962363

EPI-743 in Friedreich's Ataxia Point Mutations

A Phase 2A Clinical Trial of EPI-743 (Vincerinone™) on Visual Function in Friedreich's Ataxia Patients With Point Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's Ataxia point mutations

Detailed description

The primary objective of this study is to investigate whether treatment with EPI-743 has a discernible impact on visual function-including visual acuity, visual fields and color vision as well as on any of a number of functional and subject/clinician-rated scales relevant in the treatment of Friedreich's ataxia, and to determine the safety of treatment with EPI-743.

Conditions

• Friedreich's Ataxia

Interventions

Type	Name	Description
DRUG	EPI-743	EPI-743 (alpha-tocotrienol quinone) is a small molecule therapeutic that was rationally designed to replete reduced glutathione through NQO1-catalyzed electron transfer from NADPH.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-10-14
• Last updated: 2016-06-29

Locations

1 site across 1 country: United States