NCT02025608已完成4 期
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week, Multicenter Study of 0.25mg Pramipexole vs. Placebo in Patients With RLS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in heart rate activations during sleep from baseline to 4 weeks
研究概览
简要总结
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pramipexole
Experimental
Pramipexole, 0.25 mg, daily for 4 weeks
干预措施: Pramipexole (Drug)
Placebo
Placebo Comparator
Placebo, daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in heart rate activations during sleep from baseline to 4 weeks
时间窗: Baseline, Week 4
Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep
次要结局
- Change in baroreflex from baseline to 4 weeks(Baseline, Week 4)
- Change in blood serum markers from baseline to 4 weeks(Baseline, Week 4)
研究者
Mauro Manconi
Dr. med.
Ospedale Regionale di Lugano
研究点 (2)
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