NCT00747487

Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy

A Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Patients With Leber's Hereditary Optic Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.

Detailed description

The study involves 6 clinic visits.

Conditions

• Leber's Hereditary Optic Neuropathy

Interventions

Type	Name	Description
DRUG	Idebenone	Idebenone 900 mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-09-05
• Last updated: 2013-05-27

Locations

3 sites across 3 countries: Canada, Germany, United Kingdom