A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 359
- 主要终点
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4
研究概览
简要总结
To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.
详细描述
This was a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off.
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
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
- •Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
- •All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
- •Taking regular doses of immediate release carbidopa/levodopa
排除标准
- •Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
- •Female subjects who are pregnant, trying to become pregnant or nursing an infant
- •Other protocol-defined inclusion/exclusion criteria applied to this study.
研究组 & 干预措施
Immediate switch
Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
干预措施: Carbidopa/levodopa/entacapone (Drug)
Delayed switch
Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
干预措施: Carbidopa/levodopa/entacapone (Drug)
结局指标
主要结局
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4
时间窗: Baseline to Week 4
Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.
次要结局
- Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8(Baseline to Week 8)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment(Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group))
- Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment(Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group))
- Change in Parkinson's Disease Quality of Life Score From Baseline to Week 4(Baseline to Week 4)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8(Baseline to Week 8)
- Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4(Baseline to Week 4)
- Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8(Baseline to Week 8)
- Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment(Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group))