Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
研究概览
简要总结
The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.
详细描述
The aim is to measure variability in plasma levodopa levels during the following three treatments:
Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease
- •Duodopa treatment ongoing
- •Hoehn & Yahr stage 3-5 at worst
排除标准
- •Ongoing treatment with COMT inhibitors
- •Psychosis
- •Treatment with typical neuroleptics
- •Contraindications for entacapone or tolcapone
研究组 & 干预措施
1. Duodopa, optimised dose
干预措施: levodopa/carbidopa (Drug)
2. 80% Duodopa + entacapone
80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
干预措施: entacapone (Drug)
3. 80% Duodopa + tolcapone
80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours
干预措施: tolcapone (Drug)
结局指标
主要结局
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
时间窗: 3 days
次要结局
- Difference in Treatment Response Scale between the treatments.(3 days)