Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study

Abstract

Background: In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity.

Aim: To assess the safety and evaluate the effects of BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle's spasms, as well as its efficacy and rate of satisfaction for patients and for the physicians.

Design: Prospective open-label study.

Population: Patients (71) with post-stroke lower limb spasticity at least 5 months by the event.

Methods: Intramuscular injections of BTX-A NT 201 in soleus, medial, and lateral gastrocnemius with a maximum total dose of 180 U. Each patients was assessed at baseline, 30, and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators.

Results: Patients treated with BTX-A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days, persisting also at 90 days of follow-up.

Conclusion: BTX-A NT 201 for the treatment of post-stroke lower limb spasticity was safe and efficacious reducing muscle tone and spasms, and improving passive ankle dorsi-flexion movement.

Clinical rehabilitation impact: These results confirmed the safety and effectiveness of a new type of BTX-A, with low immunogenity, useful to improve rehabilitative treatment of post-stroke lower limb spasticity.