NCT00363727已完成3 期
A Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 70
- 主要终点
- Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
研究概览
简要总结
This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
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
- Double
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
- •Must be on 600mg or less of levodopa therapy for two years or less.
- •Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.
排除标准
- •Current or past history of Dyskinesia.
- •State of dementia or have a MMSE score < 26 at screening.
结局指标
主要结局
Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
时间窗: Up to 2 Years
Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported
次要结局
- Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104(At Weeks 28 and 104)
- Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104(Baseline (Day 1), Week 28, and Week 104)
- Number of participants with symptoms of dyskinesia over period(Upto week 106)
- Change from Baseline (Day 1) in fatigue score using epworth sleepiness scale (ESS) over period(Baseline (Day 1) and up to Week 104)
- Percentage of participants with reduced PD symptom control up to 96 weeks(Up to Week 96)
- Mini mental status examination (MMSE) score status at screening and Week 104(Screening and Week 104)
- Change from Baseline (Day 1) in total score on the beck depression inventory (BDI) over period(Baseline (Day 1) and up to Week 104)
- Change from Baseline (Day 1) in night-time quality of sleep scores of the PD sleep scale (PDSS) over period(Week 28, 52, 76, and 104)
- Percentage of participants with a score of "much improved" or "very much improved" on the clinical global impression of improvement (CGI -I) up to 52 weeks(Up to 52 weeks)
- Mean change from Baseline (Day 1) in PD quality of life score (PDQ39) scale over period(Up to 104 weeks)
- Percentage of participants of genes variants of interest with and without dyskinesia over period(Up to Week 104)
研究者
研究点 (70)
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