A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 747
- 试验地点
- 32
- 主要终点
- Time to First Occurrence of Dyskinesia
研究概览
简要总结
The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of idiopathic Parkinson's disease
- •Diagnosis of Parkinson's disease for no more than 5 years
排除标准
- •History, signs, or symptoms of atypical or secondary parkinsonism
- •Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
- •Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
- •Other inclusion/exclusion criteria applied to this study.
研究组 & 干预措施
Carbidopa/levodopa/entacapone
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
干预措施: Carbidopa/levodopa/entacapone (Drug)
Immediate release carbidopa/levodopa
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
干预措施: Immediate release carbidopa/levodopa (Drug)
结局指标
主要结局
Time to First Occurrence of Dyskinesia
时间窗: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first
Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
次要结局
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)(Baseline, Week 6 and Week 130)
- Occurrence of Wearing-off(Baseline to Week 134)
- Time to First Occurrence of Wearing-off(Baseline to end of study (134-208 weeks of treatment))
- Occurrence of Dyskinesia(Baseline to Week 208)
- Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)(Baseline to Week 156)