NCT00530530已完成2 期
ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 474
- 主要终点
- The change of the International Restless Legs Syndrome rating scale score
研究概览
简要总结
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
详细描述
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
- •History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
- •Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period
排除标准
- •A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
- •A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
- •Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
研究组 & 干预措施
1
Experimental
Dose 1
干预措施: ASP8825 (Drug)
2
Experimental
Dose 2
干预措施: ASP8825 (Drug)
3
Experimental
Dose 3
干预措施: ASP8825 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The change of the International Restless Legs Syndrome rating scale score
时间窗: 12 weeks
次要结局
- Investigator-related Clinical Global Impression of Improvement(12 weeks)
- Patient- related Clinical Global Impression of Improvement(12 weeks)
- The Pittsburgh sleep quality index(12 weeks)
- The SF-36 Health Survey(12 weeks)
- The Restless Legs Syndrome QOL Questionnaire(12 weeks)
- The Medical Outcomes Study sleep scale(12 weeks)
研究者
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