drugset / Trial / NCT00905268
A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.
Timeline
- Start
- 2006-04
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idebenone | Small molecule | 180 mg | Oral |
| Subject | Idebenone | Small molecule | 360 mg | Oral |
| Subject | Idebenone | Small molecule | 450 mg | Oral |
| Subject | Idebenone | Small molecule | 900 mg | Oral |
| Subject | Idebenone | Small molecule | 1350 mg | Oral |
| Subject | Idebenone | Small molecule | 2250 mg | Oral |