Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in dyskinesia severity and duration during the levodopa infusion, measured with a clinical rating scale during two-hour levodopa infusion
研究概览
简要总结
The purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.
详细描述
Levodopa is a drug that can be taken by mouth, and improves the symptoms of Parkinson's disease (PD). However it can eventually cause involuntary movements called dyskinesia and motor fluctuations-fluctuations in the control of symptoms, often referred to as "off" and "on." Apomorphine is a drug that works as well as levodopa, but does not work if taken by mouth.
The purpose of this study is to compare the effects of apomorphine in people with PD who have levodopa-induced motor fluctuations and dyskinesias. In the trial, researchers will compare the effects of apomorphine administered by subcutaneous bolus injections (pulsatile) and by ambulatory infusion pumps (continuous) in 24 people with PD, for 6 months.
After an initial screening, potential participants will undergo a test to verify that they can tolerate and respond to apomorphine. Those who meet all of the requirements will be randomized to receive the study drug via injections (shots) using an injector pen or a portable infusion pump. Apomorphine will be given either continuously using the portable pump during the waking day or intermittently by injection, for 6 months. The pump will be carried on a belt and connected by a tube to a small needle under the skin. Injections of apomorphine under the skin will be self-administered by the participants or administered by friends or family members using injector pens.
After 6 months, the effects of apomorphine use will be assessed by measuring how the participants respond to levodopa and by measuring their symptoms during the course of the study. Participants will be followed initially every week, then biweekly, and then monthly in an outpatient clinic for 6 months. During this time, they may receive adjustments of apomorphine doses as well as doses of other antiparkinson medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson's Disease
- •clear response to levodopa (sinemet)
- •"off" at least 20% of waking day
- •dyskinesias present for at least two hours of waking day
- •subject or caregiver able to master use of drug delivery system (injector pen or pump)
排除标准
- •physical complications that would preclude safe participation
- •standing systolic BP of <80
- •lack of tolerance or response to apomorphine
- •drug/alcohol abuse
研究组 & 干预措施
Ambulatory Pump
Participants will receive apomorphine via a pump. Participants in the Continuous Delivery Arm will self-administer apomorphine continuously (12-14 hours a day) using a portable pump.
干预措施: Apomorphine (Drug)
Subcutaneous Injections
Participants will receive apomorphine via an injection pen. Participants in the Intermittent Delivery Arm will self-administer apomorphine at intervals, via a injection, using pen injector.
干预措施: Apomorphine (Drug)
结局指标
主要结局
Change in dyskinesia severity and duration during the levodopa infusion, measured with a clinical rating scale during two-hour levodopa infusion
时间窗: at baseline and after 6 months
次要结局
- Improvement in "on" time, as measured by subject diaries(at baseline and after 6 months)
- Reduction in levodopa and adjunct drug use(at baseline and after 6 months)
- Improvement in motor performance, measured as change in tapping speed during levodopa infusion(at baseline and after 6 months)
研究者
John G. Nutt
Professor of Neurology
Oregon Health and Science University