A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 20
- 主要终点
- Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
研究概览
简要总结
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
研究组 & 干预措施
pramipexole Extended release
subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement
干预措施: pramipexole extended release tablet (Drug)
pramipexole Immediate release
subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement
干预措施: pramipexole immediate release tablet (Drug)
结局指标
主要结局
Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
时间窗: Baseline and week 18
UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
次要结局
- Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Responder in Percentage Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time Without Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Duration of Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time Without Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Patient Global Impressions of Improvement (PGI-I) Responder at Week 18(18 weeks)
- Responder in UPDRS Parts II+III Score at Week 18(Baseline and week 18)
- Levodopa (L-Dopa) Dose Change During the Study(18 weeks)
- Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18(Baseline and week 18)
- Clinical Global Impression of Improvement (CGI-I) Responder at Week 18(18 weeks)
- Change From Baseline in UPDRS II Score Separately at Week 18(Baseline and week 18)
- Change From Baseline in UPDRS III Score Separately at Week 18(Baseline and week 18)
- Levodopa (L-Dopa) Introduction During the Study(18 weeks)