drugset / Trial / NCT00993967

Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)

NCT00993967

Phase 3 Completed 200 enrolled Santhera Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.

Timeline

Start
2007-06
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Idebenone Small molecule 1350 mg
Subject Idebenone Small molecule 2250 mg

Indications