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Scientists probe gene changes behind RLS drug side effects

NCT ID NCT06726785

Knowledge-focused Sponsor: HBC Immunology Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tracks gene changes in people with Restless Legs Syndrome who take dopamine agonists for different lengths of time. Researchers will collect nasal swabs from 50 participants—some new to the drugs, others on them for 6+ months—to see how key genes change. The goal is to better understand augmentation syndrome, a condition where symptoms worsen over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dopamine agonists (pramipexole, ropinirole, rotigotine, apomorphine, bromocriptine)
What this could lead to
If successful, this research could help explain why some RLS patients get worse over time with dopamine agonists, potentially pointing toward safer treatment strategies.
What could go wrong
This is a small, early observational study (50 people) measuring gene expression, not a treatment trial. It may not find clear patterns or lead directly to new treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Diagnosed with RLS and on Dopamine Agonist treatments.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Neurologic Manifestations restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Restless leg syndrome (RLS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alethios Inc

    RECRUITING

    San Francisco, California, 94109, United States

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