Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity.

ABSTRACT:

Introduction

Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.

Methods

Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). 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) vs. -0.5 ± 0.08 (n = 88); P < 0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than with placebo (37.5%; P < 0.001). Investigator's Global Impressi

SUBMITTER: Elovic EP 

PROVIDER: S-EPMC5064747 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature