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

NCT06726785 | Recruiting

• 1 other identifier: RLS_IRB_12415
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Leg Syndrome (RLS)

Keywords

restless leg syndrome; RLS; neurological

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 week

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with RLS and on Dopamine Agonist treatments.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HBC Immunology Inc: lead

Study Sites (1)

Alethios Inc

San Francisco, California, 94109, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Primary Endpoint: Nasal epithelial cell analysis for changes in dopaminergic genes expression between the two groups . Secondary Endpoints: Exploratory nasal epithelial cell swab data analysis for changes in other neural pathway genes expression between the two groups.

MeSH Terms

Conditions

Restless Legs Syndrome; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bomi Framroze, PhD

CONTACT

6502068006; bomi.framroze@hbcimmunology.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: July 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 27, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)