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

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.

KEYWORDS: :

• botulinum toxin
• clinical trials
• movement disorders
• restless legs syndrome
• sleep disorders