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

NCT ID: NCT06726785

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Restless Leg Syndrome (RLS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HBC Immunology Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Bomi Framroze

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alethios Inc

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bomi Framroze, PhD

Role: CONTACT

6502068006

Facility Contacts

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Zeenia Framroze, MA

Role: primary

650-206-8006

Other Identifiers

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RLS_IRB_12415

Identifier Type: -

Identifier Source: org_study_id

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