CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 232 enrolled
Drug / intervention
idebenone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00905268
NCT00905268Phase 3Completed
CompareCT.gov

A Phase III Double-blind, Randomised, Placebo-controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

Santhera Pharmaceuticals·interventional·Posted May 20, 2009·Updated Jun 27, 2016

In Brief

A Phase 3 clinical trial evaluating idebenone and Placebo for Friedreich's Ataxia. Completed, enrolled 232 participants across 13 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesAustria, Belgium, France, Germany, Netherlands, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2009
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.1 years ago

Interventions

idebenonedrug

12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Placebodrug

12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.