NCT00167609已完成2 期
Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy
University of Versailles12 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Variation in a Muscle Strength Score between randomization and study week 12
研究概览
简要总结
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy
详细描述
Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with DHEA in adults with myotonic dystrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myotonic dystrophy (genetically proven)
- •MDRS score of 3 or 4
排除标准
- •Age <18 years or >70 years
- •Pregnancy or breastfeeding
- •Poor compliance to treatment and follow up
- •Inclusion in any other clinical trial
- •Severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia)
- •Chronic renal failure
- •Chronic liver disease
- •Long term mechanical ventilation
- •Any ongoing cancer
- •Any underlying endocrine disorders
- •Impaired swallowing
- •Previous treatment with DHEA
结局指标
主要结局
Variation in a Muscle Strength Score between randomization and study week 12
时间窗: 3 months
次要结局
- evaluation of myotonia(3 months)
- Appeal score(3 months)
- Epworth score(3 months)
- Forced vital capacity(3 months)
- arterial blood gas(3 months)
- changes in EKG and echocardiography(3 months)
- tolerance(3 months)
研究者
研究点 (12)
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