Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 549
- 试验地点
- 1
- 主要终点
- Frequency Analysis for Baseline Pattern of RLS Symptoms
研究概览
简要总结
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
研究设计
- 研究类型
- Observational
- 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
- •Primary Restless Legs Syndrome (i.e. idiopathic RLS)
- •Indication for treatment with pramipexole
- •Male or female patients older than 18 years
排除标准
- •Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
- •Current treatment with pramipexole
结局指标
主要结局
Frequency Analysis for Baseline Pattern of RLS Symptoms
时间窗: Baseline
Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
Change in Total Scores of IRLS (International Restless Legs Rating Scale)
时间窗: Baseline and final visit (week12)
The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value.
Change in Global Clinical Impression - Improvement (CGI-I) Scale
时间窗: baseline and final visit (week 12)
The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
Frequency of Adverse Events
时间窗: Up to 16 weeks
Frequency of patients with any adverse event, causally related adverse events and serious adverse events
Correlation of the Change in IRLS at End of Titration and at Final Visit
时间窗: Up to 12 weeks
Correlation of the change in IRLS at end of titration and at final visit
次要结局
未报告次要终点