Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells.
研究概览
简要总结
The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.
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
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide Informed Consent
- •Clinical diagnosis of Restless Legs Syndrome (RLS)
- •On-going Treatment with a dopamine agonist
排除标准
- •* Use of any medication that might affect nasal epithelial cell collection with a nasal swab
结局指标
主要结局
To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells.
时间窗: 1 week
Gene expression will be measured and reported as the Fold change, which is the ratio of expression levels between the DRD2 experimental gene vs GAPDH housekeeping gene expression and reported as the Fold change which will indicate the magnitude of upregulation or downregulation of the DRD2 gene. A fold change \>= 2 will be used as the minimum baseline to indicate upregulation and a fold change \< = 1/2 will be used as the minimum baseline to indicate downregulation.
次要结局
未报告次要终点
研究者
Bomi Framroze
Principal Investigator
HBC Immunology Inc
