title: Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity.
abstract: BACKGROUND
  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.
authors.affiliation: HealthSouth Rehabilitation Hospital of Utah, 8074 South 1300 East, Sandy, Utah, 84094, USA.
authors.forename: Elie Paul
authors.initials: EP
authors.lastname: Elovic
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Munin
authors.affiliation: Faculty of Medicine and Dentistry and University Hospital, Palacky University Olomouc, Olomouc, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Kaňovský
authors.affiliation: Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Hanschmann
authors.affiliation: Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Hiersemenzel
authors.affiliation: Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine and Rehabilitation Institute of Chicago, Chicago, Illinois, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Marciniak
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications; D034941:Upper Extremity / Q000503:physiopathology*; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA
keywords: Xeomin; botulinum toxins, type A; incobotulinumtoxinA; muscle spasticity; stroke