Restless Legs Syndrome Treatment With Botulinum Toxin

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: IPSEN PHARMA S.A.S
• Treatments: Botulinum Toxins

Criteria

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