Observing gene changes in patients with Restless Legs Syndrome on dopamine treatment
Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)
This study is trying to see how long-term treatment with dopamine medication affects gene changes in people with Restless Legs Syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | HBC Immunology Inc Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06726785 on ClinicalTrials.gov |
What this trial studies
This study aims to observe changes in the expression of dopaminergic genes in nasal swabs from patients with Restless Legs Syndrome (RLS) who are undergoing prolonged treatment with dopamine agonists. Participants will be divided into two groups: those who have not used a dopamine agonist or have been on it for less than one month, and those who have been treated for six months or more. The study will analyze how these treatments affect gene expression, particularly in relation to Augmentation Syndrome, which can occur with long-term dopamine agonist use. The findings may provide valuable insights into the regulation of dopaminergic genes in RLS patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Restless Legs Syndrome who are currently receiving treatment with a dopamine agonist.
Not a fit: Patients who are not on dopamine agonist treatment or those using medications that affect nasal epithelial cell collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of gene regulation in RLS and improve treatment strategies for patients.
How similar studies have performed: Similar studies in Parkinson's disease have shown changes in gene expression, suggesting potential for success in this novel approach for RLS.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- Alethios Inc — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Bomi Framroze, PhD
- Email: bomi.framroze@hbcimmunology.com
- Phone: 6502068006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.