Status:
COMPLETED
Restless Legs Syndrome Treatment With Botulinum Toxin
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
IPSEN PHARMA S.A.S
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 av...
Detailed Description
The restless legs syndrome (RLS) is a chronic sensori-motor disorder affecting an estimated 7.2% to 11.5% of the adult population. It is characterised by a complaint of an irresistible urge to move th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00949806
Start Date
August 1 2009
End Date
November 1 2011
Last Update
July 19 2012
Active Locations (1)
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1
CHU de Bordeaux
Pessac, France, 33600