Determining the Natural History of Levodopa-Induced Dyskinesia (LID)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Levodopa-Induced Dyskinesia
研究概览
简要总结
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.
详细描述
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •At least 21 years of age
- •Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.
排除标准
- •Unable to stand for 1 minute intervals
- •Sensory deficits in the feet
- •Significant cognitive impairment
- •Unstable medical or psychiatric conditions (including hallucinations)
- •History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)
研究组 & 干预措施
PD Cohort
The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa.
干预措施: Levodopa (delivered intravenously) (Drug)
结局指标
主要结局
Levodopa-Induced Dyskinesia
时间窗: 5 years
次要结局
未报告次要终点