Restless Legs Syndrome Treatment With Botulinum Toxin (NCT00949806) | Clinical Trial Compass
CompletedPhase 2
Restless Legs Syndrome Treatment With Botulinum Toxin
France27 participantsStarted 2009-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of BNT in the treatment of RLS measured by at least 50% improvement of the RLS severity score as measured by the International Restless Legs Syndrome Severity Scale (IRLSRS) at day 15 following BNT injection
Timeframe: Outcome measures will be evaluated at baseline, then at 2, 6, 12, 18 and 24 weeks.