NCT00577460已完成3 期
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 70
- 主要终点
- Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
研究概览
简要总结
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).
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
- 32 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
Active Comparator
Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily
干预措施: Pramipexole (Drug)
Placebo
Placebo Comparator
Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
时间窗: 80 weeks
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
次要结局
- Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III(One week)
- UPDRS II+III Change From Open Label (OL) Baseline(OL Baseline and week 80)
- Number of Participants With UPDRS II+III Response(Week 80)
- Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time(One week)
- Percentage Off Time During Waking Hours Total Score: Change From Baseline(Baseline and week 80)
- Number of Participants With Response in Percentage Off Time During Waking Hours(80 weeks)
- Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
- Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
- Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
- Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
- Number of Participants With Response in CGI-I(32 weeks)
- Number of Participants With Response in PGI-I(32 weeks)
- Number of Participants With Response in PGI-I for Early Morning Off Symptoms(32 weeks)
- UPDRS I Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
- UPDRS II Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
- UPDRS III Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
- UPDRS IV Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
- Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80(OL baseline and week 80)
- Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80(OL baseline and week 80)
- Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline(OL baseline and week 80)
- Number of Participants With Serious Adverse Events(80 weeks)
- Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
- Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set(OL Baseline and Week 80)
- Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set(Baseline, 80 weeks)
研究者
研究点 (70)
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