EUCTR2005-002520-33-BE进行中（未招募）不适用
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
Santhera Pharmaceuticals LLC0 个研究点目标入组 21 人开始时间: 2005年10月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients 10 – 16 years of age at time of enrolment
- •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/< 5% dystrophin protein on muscle biopsy; clinical picture consistent of typical DMD)
- •If on chronic glucocorticosteroids treatment (deflazacort, prednisone) for DMD (or any other disease): dosage must be stable (unchanged) 6 months prior to inclusion
- •If on chronic medication for DMD associated cardiomyopathy (ß-blocker, diuretics): dosage must be stable (unchanged) 3 months prior to inclusion
- •Ability to provide reproducible repeat QMT upper limb score within 15% of first assessment score (at Visit 1/Day 1 vs. screening)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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