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临床试验/NCT00560508
NCT00560508已完成2 期

A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER

Boehringer Ingelheim19 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2007年11月最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
112
试验地点
19
主要终点
Percentage of Participants Who Experienced Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

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
1 Year 至 —（Child, 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

Experimental

patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID

干预措施: Pramipexole Extended Release (Drug)

Pramipexole Immediate Release

Active Comparator

patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID

干预措施: Pramipexole Immediate Release (Drug)

结局指标

主要结局

Percentage of Participants Who Experienced Adverse Events

时间窗: 12 weeks

An adverse event is defined as any untoward medical occurrence

次要结局

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score(baseline and after 12 weeks treatment)
  • Change From Baseline in Percentage Off-time(baseline and after 12 weeks treatment)
  • Change From Baseline in Percentage On-time Without Dyskinesia(baseline and after 12 weeks treatment)
  • Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia(baseline and after 12 weeks treatment)
  • Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia(baseline and after 12 weeks treatment)
  • Change From Baseline in UPDRS Part II Score(baseline and after 12 weeks treatment)
  • Change From Baseline in UPDRS Part III Score(baseline and after 12 weeks treatment)
  • Change From Baseline in UPDRS Part IV Score(baseline and after 12 weeks treatment)
  • UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)(baseline and after 12 weeks treatment)
  • Change From Baseline in L-dopa Daily Dose(baseline and after 12 weeks treatment)
  • Trough Plasma Concentration at Steady State(at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment)
  • Change From Baseline in Percentage On-time With Troublesome Dyskinesia(baseline and after 12 weeks treatment)
  • Responder Rate For Clinical Global Impression of Improvement (CGI-I)(baseline and after 12 weeks treatment)
  • Responder Rate For Patient Global Impression of Improvement (PGI-I)(baseline and after 12 weeks treatment)
  • Change From Baseline in UPDRS Part I Score(baseline and after 12 weeks treatment)
  • Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
  • Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment(from Visit 1 to Visit 8 after pramipexole ER)
  • Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
  • Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
  • UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
  • Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)(Baseline and after 64 weeks treatment)
  • Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
  • Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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