NCT00537680

Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

A Phase III Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Friedreich's Ataxia

Interventions

Type	Name	Description
DRUG	Idebenone	Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day
DRUG	Idebenone	Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day
DRUG	Placebo	Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-10-01
• Last updated: 2023-07-11
• Results posted: 2011-12-29

Locations

2 sites across 1 country: United States