Swiss Restless Legs Syndrome Trial (SRLS) A Double-blind, Randomised, Crossover Trial Investigating the Efficacy and Safety of the Dopamine Agonist Pramipexole (Sifrol®, 0.25-0.75 mg Per Day) Versus Levodopa / Benserazide (Madopar® DR, 125-375 mg Per Day) in Patients With Restless Legs Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 7
- 主要终点
- Frequency of periodic limb movements while in bed (PLM-I)
研究概览
简要总结
The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Frequency of periodic limb movements while in bed (PLM-I)
时间窗: after 4 weeks
次要结局
- Changes in Quality of Life (SF-36)(after 4 weeks)
- Changes in RLS-score(after 4 weeks)
- Mood changes measured by Hospital Anxiety and Depression Scale (HAD)(after 4 weeks)
- Overall impression assessed by Clinical Global Impression (CGI)(after 4 weeks)
- Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)(after 4 weeks)
- Changes in sleep quality as assessed in a sleep diary(after 4 weeks)
- Incidence and Intensity of Adverse events(up to 10 weeks)
- Changes in safety laboratory values(up to 10 weeks)