NCT00697073

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

Detailed description

The study involves 6 clinic visits.

Conditions

• Friedreich's Ataxia

Interventions

Type	Name	Description
DRUG	Idebenone	Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-06-13
• Last updated: 2023-07-11
• Results posted: 2011-08-04

Locations

2 sites across 1 country: United States