Recruiting

Dopamine Agonist

Sponsor:

HBC Immunology Inc

Code:

NCT06726785

Conditions

Restless Leg Syndrome (RLS)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT06726785

Start date

Jul 1, 2025

Status verified date

Sep, 2025

Completion date

Feb 27, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells. [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Locations

Alethios Inc

Recruiting

San Francisco, California, United States, 94109

Contacts

More Information

Sponsor

HBC Immunology Inc

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • restless leg syndrome
  • RLS
  • neurological

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HBC Immunology Inc on 2025-09-11.