NCT00239486已完成2 期
Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 18-80 years
- •Confident diagnosis of RLS according to International RLS Study Group criteria
- •RLS rating scale for severity score >15
- •PLM (during time in bed ) index at least 5 per hour
- •Weekly presence of RLS symptoms within last three months
- •Written Informed consent
排除标准
- •Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception
- •Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection
- •Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom
- •Any women not having negative serum pregnancy test at screening
结局指标
主要结局
Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).
时间窗: 3 weeks
次要结局
- Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).(3 weeks)
研究者
研究点 (2)
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