Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 119
- 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 ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) 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
- 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
Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
干预措施: Pramipexole (Drug)
Placebo
Patient 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 (patients from 248.524) or 72 weeks (patients from 248.636)
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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline(Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)(OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- UPDRS I Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- UPDRS II Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- UPDRS III Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- Response in Clinical Global Impression of Improvement (CGI-I)(OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636))
- Response in Patient Global Impression of Improvement (PGI-I)(OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636))
- Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- Number of Patients Introducing L-Dopa Medication in OL Trial(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))
- L-Dopa Dose: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
- Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients(Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636))
- Patient Preference Regarding Treatment Dosing(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))
- Patient Rating of Convenience of Treatment Dosing(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))