At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 65 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 900 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, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy
In Brief
A Phase 3 clinical trial evaluating Placebo and Idebenone for Muscular Dystrophy, Duchenne and Ambulatory Care. Completed, enrolled 65 participants across 23 sites in 10 countries.
Detailed Summary
The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Dystrophy, Duchenne, Ambulatory Care
CountriesAustria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedDec 2009
Primary CompletionJan 2014
Study CompletionApr 2014
TodayJul 2026
First PostedDec 9, 2009
Enrollment StartJul 1, 2009
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.6 years ago
Interventions
Placebodrug
Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
Idebenonedrug
Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals