Efficacy and safety of NT 201 for upper limb spasticity of various etiologies--a randomized parallel-group study

Abstract

Objective: To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) in patients with upper limb spasticity of diverse etiology.

Methods: Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment.

Results: One hundred ninety-two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post-injection, a ≥ 1-point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in ≥ 62.2% of patients. The 20 U/ml NT 201 dilution was non-inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%).

Conclusions: NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions.