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Research Article

Pilot Trial of OnabotulinumtoxinA (Botox) in Moderate to Severe Restless Legs Syndrome

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Pages 622-625 | Received 13 Apr 2011, Published online: 10 Aug 2011
 

ABSTRACT

Objective: To evaluate the potential of onabotulinum toxin A (Botox®, Allergan, Inc., Irvine, California) in the treatment of restless legs syndrome (RLS). Methods: A single-arm, open-label pilot trial of onabotulinum toxin A was conducted to determine its usefulness as an injectable treatment for RLS. Results: The primary outcome measure, change in score on the International Restless Legs Syndrome Scale, showed a statistically significant improvement in RLS during the first 4 weeks after treatment. Two of the secondary outcome measures, pain (measured using a visual analog scale) and patients’ global impression of severity of illness also showed improvement. Conclusions: Onabotulinum toxin A warrants further study in RLS. Increasing the drug dosage, changing the dosing schedule, and increasing the number of injection sites may result in greater activity and longer duration of action.

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