What this study is
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.
Study details
- Official title
- Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)
- Sponsor
- HBC Immunology Inc
- Conditions
- Restless Leg Syndrome (RLS)
- Enrolling
- 50 people
- Starts
- 2025-07-01
- Est. completion
- 2026-02-27
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Able to provide Informed Consent
- Clinical diagnosis of Restless Legs Syndrome (RLS)
- On-going Treatment with a dopamine agonist
You can't join if
- Use of any medication that might affect nasal epithelial cell collection with a nasal swab
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAlethios Inc
San Francisco, California, United States
- Zeenia Framroze, MA · Contact650-206-8006zeenia@alethios.com
Recruiting
Study team
Sponsor
HBC Immunology Inc
Study ID RLS_IRB_12415
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.