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临床试验/NCT04064294
NCT04064294已完成不适用

Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With Statins

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2019年8月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
3
主要终点
Peak Unified Dyskinesia Rating Score (UDysRS)

研究概览

简要总结

In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System.

详细描述

Long term treatment with levodopa, the gold standard treatment of Parkinson's disease (PD), can lead to the development of abnormal involuntary movements called levodopa induced dyskinesia (LID). The severity of LID can range from mild to severely debilitating. A majority of PD patients will develop LID in their treatment life-time. In a recent study of the MPTP monkey model of PD, statin use was found to reduce LID (45%) without a worsening of Parkinsonism symptoms1. Another study showed rats treated with lovastatin prior to and with initiation of levodopa after substantia nigra lesioning showed dramatically less LID evolution compared to animals without lovastatin exposure2. In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System. This study is a retrospective three cohort design and will compare statin exposure BEFORE beginning LD, versus statin exposure AFTER LD is begun, versus NO statin exposure in PD subjects controlling for disease characteristics (severity), gender, and total LD exposure The primary endpoint is the severity of LID between the groups after years of opportunity to develop LID. Levodopa-Induced dyskinesia is a major cause of reduced quality of life for Veterans with PD and, in some cases, leads to costly surgical interventions. This project examines the impact of statin use on the presence of LID, and could lead to a future intervention trial. The reduction, delayed onset, or elimination of LID could improve the quality of life of many Veterans nationwide.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson's Disease
  • Age diagnosed with Parkinson's Disease greater than or equal to 50 years
  • Treatment with levodopa greater than or equal to 5 years

排除标准

  • Deep Brain stimulation
  • Unable to stand for 1 minute intervals, or sensory deficits in the feet
  • Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of < 18
  • Subjects with unstable medical or psychiatric conditions (including hallucinations).
  • History of unstable medical conditions (i.e. active cardiac disease, recent unwellness, surgery etc.)
  • Current use of drugs that may affect parkinsonism or dyskinesia:
  • dopamine receptor blocking medications
  • amiodarone
  • tetrabenazine
  • metoclopramide
  • dronabinol
  • and illicit drugs such as marijuana (THC)
  • methamphetamine
  • Statins other than simvastatin or lovastatin, atorvastatin ie. fluvastatin (rationale is that while all other statins are thought to not cross the blood brain barrier well, the central nervous system penetrating nature of others is not perfectly clear and could confound results)

研究组 & 干预措施

Statin Before Levodopa

Historical use of a statin BEFORE beginning levodopa

干预措施: Intravenous Infusion (Drug)

Statin After Levodopa

Historical use of a statin AFTER beginning levodopa

干预措施: Intravenous Infusion (Drug)

No Statin

No historical use of a statin

干预措施: Intravenous Infusion (Drug)

结局指标

主要结局

Peak Unified Dyskinesia Rating Score (UDysRS)

时间窗: 11:00 am

The Unified Dyskinesia Rating Scale (UDysRS) combines patient, caregiver, and treating physician perspectives on both historical (Parts 1 \& 2) and objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The historical portion and the objective ratings are added together to form total score ranging from 0 to 104 with higher scores indicating more severe dyskinesia.

次要结局

  • Peak Unified Dyskinesia Rating Scale - Objective Measures(11:00 am)
  • Presence/Absence of Levodopa-induced Dyskinesia (LID).(Every half hour from 0900 to 1500)
  • Clinical Dyskinesia Rating Scale (Peak)(11:00 am)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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