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Restless Legs Syndrome Treatment With Botulinum Toxin
Sponsor: University Hospital, Bordeaux
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.
Official title: Phase II Non Comparative, Open Study to Assess the Efficacy and Safety of the Botulinum Toxin Type A in Patients With Restless Legs Syndrome (RLS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2009-08
Completion Date
2011-11
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
CHU de Bordeaux
Pessac, France