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Restless Legs Syndrome Treatment With Botulinum Toxin

NCT00949806 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-05-12

No results posted yet for this study

Summary

Restless Legs Syndrome (RLS) is a common sensori-motor disorder that causes sensory discomfort and motor restlessness, most often in the legs, which improves with movement. Although medications are available to treat the disorder, many people either experience side effects that prevent them from continuing on the medication or do not sufficiently respond to current RLS medications. Recently, botulinum toxin type A (BNT) has been reported to relief RLS in patients with severe symptoms but this was not confirmed by other anecdotal reports. The investigators propose to test the efficacy of BNT on RLS symptoms by designing a more controlled study. Ultimately, this may lead to extend the therapeutic arsenal of this disorder.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

BNT (intradermal injection)

Patients with severe RLS will receive a one-time intradermal administration of BNT into the most symptomatic areas of both legs. Injections will be distributed in a grid distribution pattern covering a total of 20 equidistant sites per symptomatic area. Each symptomatic area will receive a maximum 250 units of BNT (12.5 units per injection). The total BNT injected units should not exceed 1000 units per patient.

Sponsors & Collaborators

  • IPSEN PHARMA S.A.S

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Imad GHORAYEB, MD, PhD · University Hospital Bordeaux, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-05-31
Completion
2011-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949806 on ClinicalTrials.gov