Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)
研究概览
简要总结
Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.
ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at >10mg/day is limited.
For this reason, this study was designed as a multicenter open-label uncontrolled study.
This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
研究组 & 干预措施
Ropinirole Hydrochloride
干预措施: ROP (Drug)
Ropinirole Hydrochloride
干预措施: ROP+L-Dopa (Drug)
结局指标
主要结局
Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)
时间窗: Baseline, Week 52, and FAP (up to Week 52)
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 and those prematurely withdrawn were not included at Week 52.
次要结局
- Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group(Baseline, Week 52, and FAP (up to Week 52))
- Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group(Baseline, Week 52, and FAP (up to Week 52))
- Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group(Baseline, Week 52, and FAP (up to Week 52))
- Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group(Baseline, Week 52, and FAP (up to Week 52))
- Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group(Baseline, Week 52, and FAP (up to Week 52))
- Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group(Baseline, Week 52, and FAP (up to Week 52))
- Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP(Baseline, Week 52, and FAP (up to Week 52))
- Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group(Baseline, Week 52, and FAP (up to Week 52))
- Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group(Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group)
- Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group(Baseline, Week 52, and FAP (up to Week 52))
- Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group(Baseline, Week 52, and FAP (up to Week 52))
- Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group(Days 0-422)
- Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group(Days 0-419)
- Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP(Week 52 and FAP (up to Week 52))
- Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline(Baseline, Week 52, and FAP (up to Week 52))