title: AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial.
abstract: BACKGROUND
  Although botulinum toxin is a well-established treatment of focal spasticity in cerebral palsy, most trials have been small, and few have simultaneously assessed measures of muscle tone and clinical benefit.
  
  
  METHODS
  Global, randomized, controlled study to assess the efficacy and safety of abobotulinumtoxinA versus placebo in cerebral palsy children with dynamic equinus foot deformity. Patients were randomized (1:1:1) to abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injections into the gastrocnemius-soleus complex (1 or both legs injected). In the primary hierarchical analysis, demonstration of benefit for each dose required superiority to placebo on the primary (change in Modified Ashworth Scale from baseline to week 4) and first key secondary (Physician's Global Assessment at week 4) end points.
  
  
  RESULTS
  Two hundred and forty-one patients were randomized, and 226 completed the study; the intention to treat population included 235 patients (98%). At week 4, Modified Ashworth Scale scores significantly improved with abobotulinumtoxinA; mean (95% confidence interval) treatment differences versus placebo were -0.49 (-0.75 to -0.23; P = .0002) for 15 U/kg/leg and -0.38 (-0.64 to -0.13; P = .003) for 10 U/kg/leg. The Physician's Global Assessment treatment differences versus placebo of 0.77 (0.45 to 1.10) for 15 U/kg/leg and 0.82 (0.50 to 1.14) for 10 U/kg/leg were also significant (both Ps < .0001). The most common treatment-related adverse event was muscular weakness (10 U/Kg/leg = 2; placebo = 1).
  
  
  CONCLUSIONS
  AbobotulinumtoxinA improves muscle tone in children with dynamic equinus resulting in an improved overall clinical impression and is well tolerated.
authors.affiliation: Texas Scottish Rite Hospital for Children, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas; mauricio.delgado@tsrh.org.
authors.forename: Mauricio R
authors.initials: MR
authors.lastname: Delgado
authors.affiliation: Louisiana State University Health Center and Children's Hospital New Orleans, New Orleans, Louisiana;
authors.forename: Ann
authors.initials: A
authors.lastname: Tilton
authors.affiliation: Shriner's Hospital for Children, Portland, Oregon;
authors.forename: Barry
authors.initials: B
authors.lastname: Russman
authors.affiliation: Centro de Rehabilitacion Infantil, Mexico City, Mexico;
authors.forename: Oscar
authors.initials: O
authors.lastname: Benavides
authors.affiliation: Non-public Healthcare Unit Mazovian Neurorehabilitation and Psychiatry Center in Zagorze, Wiazowna, Poland;
authors.forename: Marcin
authors.initials: M
authors.lastname: Bonikowski
authors.affiliation: Hospital San José Celaya, Celaya, Guanajuato, Mexico;
authors.forename: Jorge
authors.initials: J
authors.lastname: Carranza
authors.affiliation: Children's Hospital of Michigan, Detroit, Michigan;
authors.forename: Edward
authors.initials: E
authors.lastname: Dabrowski
authors.affiliation: Kocaeli University Medical Faculty, Izmit, Turkey;
authors.forename: Nigar
authors.initials: N
authors.lastname: Dursun
authors.affiliation: Gillette Children's Specialty Healthcare, St Paul, Minnesota;
authors.forename: Mark
authors.initials: M
authors.lastname: Gormley
authors.affiliation: Department of Pediatric Orthopedics and Traumatology K. Marcinkowski University of Medical Sciences, Poznan, Poland;
authors.forename: Marek
authors.initials: M
authors.lastname: Jozwiak
authors.affiliation: Children's Hospital Colorado, Aurora, Colorado;
authors.forename: Dennis
authors.initials: D
authors.lastname: Matthews
authors.affiliation: Rehabilitation Center KROK PO KROKU, Gdansk, Poland;
authors.forename: Iwona
authors.initials: I
authors.lastname: Maciag-Tymecka
authors.affiliation: Yildirim Beyazit Training and Research Hospital, Ankara, Turkey; and.
authors.forename: Ece
authors.initials: E
authors.lastname: Unlu
authors.affiliation: Ipsen, Les Ulis, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Pham
authors.affiliation: Ipsen, Les Ulis, France.
authors.forename: Anissa
authors.initials: A
authors.lastname: Tse
authors.affiliation: Ipsen, Les Ulis, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Picaut
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D000293:Adolescent; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000150:complications*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004863:Equinus Deformity / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007273:Injections, Intramuscular; D009129:Muscle Tonus; D018908:Muscle Weakness / Q000139:chemically induced; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D004856:Postural Balance; D011446:Prospective Studies; D016138:Walking
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA