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Botox injection shows promise for restless legs relief

NCT ID NCT00949806

Symptom relief Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether botulinum toxin type A (like Botox) can ease symptoms of restless legs syndrome (RLS) in 27 adults who did not get enough relief from standard treatments. Participants received one injection, and researchers checked if leg discomfort and urge to move improved by at least half over 24 weeks. The goal is to offer a new option for people with severe RLS.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

27 people

The number who actually took part.

Start date

Aug 2009

Finished

Nov 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Male or female \> 18 years old * Normal neurological clinical examination * A minimum score of 21 on the RLS severity rating scale * Primary RLS diagnosis based on (i) the presence of a characteristic clinical history and on (ii) the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria. * Medications regimen for RLS must be stabilized for more than 6 weeks prior to entering the study * informed consent Exclusion Criteria: * Medical history of diabetes, depression, kidney failure, myasthenia * Iron deficiency * Pregnancy, lactation, woman of childbearing age without efficient contraceptive method * Patient undergoing aminosid antibiotherapy or BNT injection for other indication * Any contra-indication to BNT injection * Participation to other clinical study within 30 days * Patient under any administrative or legal supervision

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Conditions

The condition(s) this trial relates to.

restless legs syndrome

As listed by the trial registrant

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

Restless legs syndrome

Contacts and locations

Locations

  • CHU de Bordeaux

    Pessac, 33600, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.