NCT00851461已完成4 期
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- muscle power
研究概览
简要总结
This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA
Objective:
- To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
- To demonstrate physiological and pathological changes in treated patients with Goserelin.
- To assess tolerability and adverse effect of Goserelin therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Males, age over 20 years, undesired fertility
- •Have positive family history of muscle weakness with these clinical signs:
- •bulbar involvement (difficulty in breathing, swallowing, talking)
- •muscle atrophy with or without fasciculation
- •decrease or normal deep tendon reflex
- •normal Babinski response
- •no sensory impairment
- •mild tremor (either postural or intention)
- •gynecomastia
- •decrease libido and infertility
- •Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.
排除标准
- •Have weakness caused by other etiologies and have liver or kidney disease.
- •Have currently prostatic cancer
- •Want to have a child
- •Participation in a clinical study during the last 30 days.
- •Females and children age < 20 years old
结局指标
主要结局
muscle power
时间窗: every 3 months
次要结局
- electrophysiologic study (Nerve conduction and Electromyogram)(every 3 months)
研究者
研究点 (2)
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