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临床试验/NCT00472355
NCT00472355撤回2 期

Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Oregon Health and Science University2 个研究点 分布在 1 个国家开始时间: 2005年10月最近更新:
适应症
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

John G. Nutt

Professor of Neurology

Oregon Health and Science University

研究点 (2)

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