NCT00993967

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

A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Freidreich's Ataxia

Interventions

Type	Name	Description
DRUG	idebenone	Idebenone 1350 mg/d, patients \< or equal 45 kg Idebenone 2250 mg/d, patients \> 45 kg

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-10-14
• Last updated: 2018-03-05
• Results posted: 2018-03-05

Locations

11 sites across 5 countries: Austria, Belgium, France, Germany, Netherlands