Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Effects on parkinsonism measured with finger and foot tapping speed
研究概览
简要总结
The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease.
详细描述
The goal of the study is to learn why some people with Parkinson's disease (PD) get worse right after taking PD medication such as carbidopa/levodopa or as the medication is wearing off.
In this study scientists will determine if apomorphine, a drug used to treat symptoms of PD, will worsen the motor symptoms of people with PD when low doses of the drug are given as a continuous subcutaneous infusion. A continuous subcutaneous infusion means the drug is administered continuously through a small needle placed under the skin. Apomorphine, a PD drug that works similar to carbidopa/levodopa, will be used in this study because it is faster-acting and has a more brief effect than carbidopa/levodopa.
After the initial screening, participants will enter a 3-day treatment phase during which they will receive in random order low dose apomorphine, high dose apomorphine, or placebo (inactive substance). All participants will receive the study drug for 2 of the days at 2 different doses (low and high) and a placebo for 1 day. During the 3 days participants will provide blood samples and have their hearts monitored. Parkinsonism will be monitored each day by speed of finger tapping, foot tapping and walking as well as tremor and dyskinesia scores.
Duration of the study for participants is approximately 4 to 5 days including 1-2 outpatient visits and a 3-day inpatient hospital stay.
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
入排标准
- 年龄范围
- 35 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have idiopathic Parkinson's disease treated with levodopa and experiencing motor fluctuations
- •Response to levodopa had to be documented by a 10 percent increase in finger or foot tapping speed
排除标准
- •Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases
- •Psychosis
- •Allergy to apomorphine or 5ht3 inhibitors
- •Prolonged qt interval
- •Pregnancy/breast-feeding
- •Hemodynamic instability
- •Severe nausea
- •Alcohol/drug abuse
- •Other unstable medical conditions
结局指标
主要结局
Effects on parkinsonism measured with finger and foot tapping speed
次要结局
未报告次要终点
研究者
John G. Nutt
Professor of Neurology
Oregon Health and Science University
