Introduction: Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.
Methods: Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow:200U; flexed wrist:150U; clenched fist:100U). Doses for non-primary patterns were flexible within predefined ranges.
Results: At Week-4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth Scale (AS) scores than placebo [least squares mean change±standard error: −0.9±0.06 (n=171) versus −0.5±0.08 (n=88); P<0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than placebo (37.5%; P<0.001). Investigator’s Global Impression of Change confirmed superiority of incobotulinumtoxinA versus placebo (P=0.003). IncobotulinumtoxinA was associated with functional improvements, demonstrated in responder rates for Disability Assessment Scale principal target at Week-4 (P=0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) subjects.
Conclusions: IncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated. This article is protected by copyright. All rights reserved.