Conditions: Friedreich's Ataxia
Keywords: Friedreich's Ataxia Idebenone ICARS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

Detailed description:
The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone.

Arms:
arm 1: mid dose Idebenone arm 2: high dose Idebenone arm 3: Placebo

Interventions: intervention 1: Idebenone intervention 2: Idebenone intervention 3: Placebo
Intervention descriptions: intervention 1: Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day intervention 2: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day intervention 3: Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.

Protocol document: