Conditions: Freidreich's Ataxia
Keywords: FRDA idebenone FRDA disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 200
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or \>45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.

Interventions: intervention 1: idebenone
Intervention descriptions: intervention 1: Idebenone 1350 mg/d, patients \< or equal 45 kg Idebenone 2250 mg/d, patients \> 45 kg

Protocol document: