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

Elie Paul Elovic*, Michael C. Munin, Petr Kaňovský, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

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 Impression of Change confirmed superiority of incobotulinumtoxinA vs. placebo (P = 0.003). IncobotulinumtoxinA was associated with functional improvements, as 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) of subjects. Conclusions: IncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated.

Original languageEnglish (US)
Pages (from-to)415-421
Number of pages7
JournalMuscle and Nerve
Volume53
Issue number3
DOIs
StatePublished - Mar 1 2016

Keywords

  • Botulinum toxins, type A
  • IncobotulinumtoxinA
  • Muscle spasticity
  • Stroke
  • Xeomin

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Cellular and Molecular Neuroscience
  • Physiology (medical)

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