At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
idebenonedrug
Likely dose
idebenone 1350 mgfrom 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.
A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients.
In Brief
A Phase 3 clinical trial evaluating idebenone for Freidreich's Ataxia. Completed, enrolled 200 participants across 11 sites in 5 countries.
Detailed Summary
This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFreidreich's Ataxia
CountriesAustria, Belgium, France, Germany, Netherlands
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedOct 2009
Primary CompletionJun 2012
TodayJul 2026
First PostedOct 14, 2009
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 16.7 years ago
Interventions
idebenonedrug
Idebenone 1350 mg/d, patients \< or equal 45 kg Idebenone 2250 mg/d, patients \> 45 kg