Successful treatment of recalcitrant restless legs syndrome with botulinum toxin type-A.

STUDY OBJECTIVE We report the effective use of injected BTX-A to treat refractory restless legs syndrome (RLS). METHODS This is an observational case series of 3 patients meeting the essential diagnostic criteria for RLS whose symptoms were refractory to or who refused oral medication. Areas of maximal discomfort were injected as described below. RESULTS Patient #1, a 58-year-old man with refractory RLS, received injections in both legs. The effect persisted for 12 weeks after injections. He temporarily stopped taking gabapentin. He experienced a mild increase in a timed run. Patient #2, a 38-year-old man with refractory RLS, received BTX-A injections in both legs and his lumbar paraspinal muscles. Three days after injection, he reported great improvement. Within 1 month, his Epworth Sleepiness Scale score had decreased from 19 to 5. He stopped oral therapy during the peak therapeutic period. There were no untoward effects. Patient #3, a 38-year-old woman had a prolonged sleep latency due to RLS. BTX-A was administered in the legs. In 2 days, her discomfort and her subjective sleep latency improved. Both the urge to move and nocturnal restlessness resolved for 10 weeks. There were no untoward effects in all patients, and the response was repeated in successive injection cycles. CONCLUSIONS Intramuscular BTX-A alleviated symptoms, reduced medication use, and/or reduced daytime sleepiness with minimal, if any, untoward effects. BTX-A should be further investigated in controlled studies as a treatment of RLS.