Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 687
- 主要终点
- Severity of Restless Legs Syndrome (RLS) at Bedtime
研究概览
简要总结
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.
详细描述
There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro®
- •The patient must have a diagnosis of moderate to severe idiopathic RLS
- •The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
- •The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
- •Subject is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Magnetic resonance imaging or cardioversion (see SmPC)
研究组 & 干预措施
Neupro®
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
干预措施: Neupro® (Drug)
结局指标
主要结局
Severity of Restless Legs Syndrome (RLS) at Bedtime
时间窗: From Baseline to end of Observation Period (3 months).
Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Severity of Restless Legs Syndrome (RLS) During the Night
时间窗: From Baseline to end of Observation Period (3 months).
Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
次要结局
- Satisfaction With Sleep(From Baseline to end of Observation Period (3 months).)
- Severity of Restless Legs Syndrome (RLS) at Daytime at Rest(From Baseline to end of Observation Period (3 months).)
- Severity of Restless Legs Syndrome (RLS) at Daytime in Activity(From Baseline to end of Observation Period (3 months).)
- Daytime Tiredness(From Baseline to end of Observation Period (3 months).)