NCT02070887撤回不适用
Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum level of homocysteine
研究概览
简要总结
The overall aim of this observational study is to investigate the impact of COMT inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or computer-based.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 - 75 years,
- •Caucasian ethnicity,
- •diagnosed PD by UK brain bank criteria,
- •Hoehn & Yahr scale 2 - 3,
- •fertile females have to use contraception
- •Group 1: medication with Stalevo® (L-DOPA/DDI + Entacapone)
- •Group 2: medication with Madopar® or Sinemet® (L-DOPA/DDI)
排除标准
- •methotrexate therapy during the last 12 months,
- •treatment with Tolcapone
- •vitamin B6, B12 and/or folic acid supplementation during last 6 months,
- •pregnancy,
- •intention to become pregnant during the course of the study,
- •breast feeding,
- •other clinically relevant concomitant disease states by discretion of the investigator
- •known or suspected non-compliance, drug or alcohol abuse,
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
- •participation in another study with investigational drug within the 30 days preceding and during the present study,
- •enrolment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
Serum level of homocysteine
时间窗: 1 year
次要结局
未报告次要终点
研究者
Christian Baumann
Professor dr. med.
University of Zurich
研究点 (1)
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