A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 82
- 主要终点
- Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)
研究概览
简要总结
This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)
时间窗: Baseline (Week 0) and Week 24
Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.
次要结局
- Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D(Baseline (Week 0) and Week 24)
- Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability(Up to Week 24)
- Percentage of participants requiring re-instatement of L-dopa(Week 24)
- Number of participants with a score of 'much improved' or 'very much improved' on the clinical global impression-global improvement (CGI-I) scale at Week 24 LOCF(Week 24)
- Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an "off" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the total Activities of daily living (ADL) score (part II) of the UPDRS, with participants in an "on" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from Baseline in the total movement severity score of the abnormal involuntary movement scale (AIMS), with participants in an "on" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the dose of L-dopa at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D)(Baseline (Week 0) and Week 24)
- Mean change from Baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an "off" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "on" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "off" state at Week 24 LOCF(Baseline (Week 0) and Week 24)
- Incidence of all adverse events (AE) and serious adverse events (SAE)(Up to Week 27)