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A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy

A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002520-33-BE
Enrollment
21
Registered
2005-10-04
Start date
2005-09-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Interventions

Product Name: idebenone Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Santhera Pharmaceuticals LLC
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: •Patients 10 – 16 years of age at time of enrolment •Male •Presence of cardiac involvement/dysfunction, defined by abnormal peak systolic strain in LV inferolateral wall •Confirmed diagnosis of DMD (out of frame dystrophin gene deletion or absent/=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Symptomatic cardiomyopathy or heart failure •Asymptomatic but severe cardiac dysfunction as Screening Visit (( evaluation): FS < 20% and/or EF < 40% •Use of ACE inhibitors •Previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at Screening •Previous (6 months or less) participation in any other therapeutic trial for DMD •Use of coenzymeQ10, idebenone, creatine, glutamine, oxatomide, or any herbal medicines within the last 6 months •History of significant concomitant illness or significant impairment of renal or hepatic function (serum creatinine and GGT greater than 1.5 times upper limit for age and gender) •Known individual hypersensitivity to idebenone

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine whether treatment with idebenone improves or slows decline in cardiac function in patients with cardiac dysfunction associated with DMD;Secondary Objective: To determine whether treatment with idebenone improves or slows decline in muscle strength and/or respiratory function in patients with DMD To evaluate the safety and tolerability of idebenone in patients with DMD To determine whether treatment with idebenone changes biochemical markers reflecting cardiac overload or cardiac degeneration ;Primary end point(s): The relative change from Baseline (at Screening) to Week 52 in peak systolic radial strain of left ventricle (LV) inferolateral wall, assessed by Color Doppler Myocardial imaging (CDMI).—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026