Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
研究概览
简要总结
The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.
详细描述
By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Clinical diagnosis of idiopathic Parkinson's disease
- •Ongoing treatment with Duodopa
- •Occurrence of dyskinesias, difficult to manage
- •Age 30-90 years
- •Hoehn & Yahr stage 3-5 at worst
排除标准
- •Treatment with dopamine agonist or glutamate antagonist
- •Psychosis
- •Treatment with typical neuroleptics
研究组 & 干预措施
1. Duodopa optimal dose
干预措施: levodopa/carbidopa (Drug)
2. Duodopa 20% too high dose
干预措施: levodopa/carbidopa (Drug)
3. Duodopa 10% too low dose
干预措施: levodopa/carbidopa (Drug)
4. Duodopa 20% too low dose
干预措施: levodopa/carbidopa (Drug)
5. Duodopa 10% too high dose
干预措施: levodopa/carbidopa (Drug)
结局指标
主要结局
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
时间窗: 3 days
次要结局
- Correlation between choreatic dyskinesia, dystonia, and parkinsonism.(3 days)