At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 70 enrolled
Drug / intervention
Idebenone +2 moredrug
Likely dose
Idebenone 450 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 Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
In Brief
A Phase 3 clinical trial evaluating Idebenone and Placebo for Friedreich's Ataxia. Completed, enrolled 70 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich's Ataxia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartDec 2007
Primary CompletionApr 2009
TodayJul 2026
First PostedOct 1, 2007
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago
Interventions
Idebenonedrug
Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day
Idebenonedrug
Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day
Placebodrug
Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.