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

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.

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Key information

Conditions

Restless Leg Syndrome (RLS) Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Restless Legs Syndrome Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alethios Inc

San Francisco, California, 94109, United States

Location status: Recruiting

Location contact

Zeenia Framroze, MA

CONTACT

[email protected]

650-206-8006

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bomi Framroze, PhD

CONTACT

[email protected]

6502068006

Sponsors and collaborators

Lead sponsor

HBC Immunology Inc

Industry

Registry information

Official study title

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

Acronym: RLS-DRD2gene

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 10, 2024
Registry last updated: Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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