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.