Non Interventional Observational Study to Collect Data for the Effect of Switching to Neupro® on Severity of Restless Leg Syndrome (RLS) Symptoms and Augmentation as Well as the Change in Treatment Regimen Used, in RLS Patients With Previous Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 102
- 试验地点
- 18
- 主要终点
- Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6
研究概览
简要总结
The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.
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
- •The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
- •The patient must be experiencing augmentation due to a prior dopaminergic treatment
- •The decision to prescribe Neupro® has been made by the physician independently of his/her decision to enroll the patient in the study
- •Patient 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
- •Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study
结局指标
主要结局
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6
时间窗: From Baseline up to 10 months
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1.
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2
时间窗: From Baseline up to 7 days
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4
时间窗: From Baseline up to 4 months
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1.
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5
时间窗: From Baseline up to 7 months
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7
时间窗: From Baseline up to 13 months
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1.
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3
时间窗: From Baseline up to 28 days
The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: 1. = Normal, not ill at all 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1.
次要结局
- Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study(From Baseline up to 28 days)