跳至主要内容
临床试验/NCT06726785
NCT06726785招募中不适用

Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)

HBC Immunology Inc1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月1日最近更新:
适应症

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

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

发起方
HBC Immunology Inc
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Bomi Framroze

Principal Investigator

HBC Immunology Inc

研究点 (1)

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