Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
研究概览
简要总结
Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.
详细描述
COMT protein is dependent of a single autosomal locus with two co-dominant alleles with a high activity (allele H) and a low activity (allele L) form of the enzyme. L and H allele frequency in the Caucasian population is around 50%. This is a monocentric randomized blinded cross-over study comparing acute challenge of L-dopa + placebo versus L-dopa + 200 mg entacapone, in Parkinson's disease patients with HH and LL genotypes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease
- •wearing off
排除标准
- •atypical parkinsonism
- •neuroleptic use
研究组 & 干预措施
L-dopa + entacapone
L-dopa + entacapone
干预措施: entacapone (Drug)
L dopa / placebo
L dopa / placebo
干预措施: l dopa versus placebo (Drug)
结局指标
主要结局
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
时间窗: during the hospitalization in 24 hours
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
次要结局
- Pharmacokinetics of L-dopa and its metabolites(at the end of the study during the last hospitalization)