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NCT06726785 · ClinicalTrials.gov registry record
Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment
A clinical trial of Restless Leg Syndrome (RLS), sponsored by HBC Immunology.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT06726785: Recruiting study of Restless Leg Syndrome (RLS), sponsored by HBC Immunology.
NCT06726785 is a study of Restless Leg Syndrome (RLS) that is actively recruiting participants, run by HBC Immunology. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06726785, a study of Restless Leg Syndrome (RLS), is actively recruiting participants, sponsored by HBC Immunology.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
California
- Alethios Inc - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2026-02-27 |
What NCT06726785 shows while recruiting
NCT06726785 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Restless Leg Syndrome (RLS) appearing as the primary indexed condition, and to 0 interventions.
NCT06726785 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06726785 about?
NCT06726785 is a clinical study titled "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 th...
What is the current status of trial NCT06726785?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-07-01. Estimated completion is 2026-02-27.
What conditions does trial NCT06726785 study?
This clinical trial studies the following conditions: Restless Leg Syndrome (RLS).
Who is sponsoring clinical trial NCT06726785?
This trial is sponsored by HBC Immunology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06726785 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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