Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06726785

Acronym

RLS-DRD2gene

Enrollment

Registered

2024-12-10

Start date

2025-07-01

Completion date

2026-02-27

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Leg Syndrome (RLS)

Keywords

restless leg syndrome, RLS, neurological

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Able to provide Informed Consent * Clinical diagnosis of Restless Legs Syndrome (RLS) * On-going Treatment with a dopamine agonist

Exclusion criteria

\* Use of any medication that might affect nasal epithelial cell collection with a nasal swab

Design outcomes

Primary

Measure	Time frame	Description
To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells.	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.

Countries

United States

Contacts

Primary ContactBomi Framroze, PhD

bomi.framroze@hbcimmunology.com6502068006

Outcome results