A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 811
- 试验地点
- 1
- 主要终点
- IRLS sum score and CGI Item 1 score severity of illness
研究概览
简要总结
Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.
The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine.
Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic restless legs syndrome
排除标准
- •History of sleep disturbances
结局指标
主要结局
IRLS sum score and CGI Item 1 score severity of illness
时间窗: From Baseline at the end of the Maintenance Period
次要结局
- IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score(From Baseline at the end of the Maintenance Period)
- CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1(From Baseline at the end of the Maintenance Period)
- Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period