NCT00027391已完成不适用
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
FDA Office of Orphan Products Development2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2001年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
研究概览
简要总结
This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.
详细描述
Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
- •Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
- •Weakness of scapular stabilizers or foot dorsiflexors
- •Ambulatory
- •Weakness grade 2 or worse in the arm using upper extremity grading scale
排除标准
- •Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
- •Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
- •Pregnancy
- •Known hypersensitivity to anabolic steroids
- •Any medical or psychological condition that would interfere with the study
- •Requirement for a wheelchair
研究者
研究点 (2)
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