title: Safety profile of incobotulinum toxin A [Xeomin(®)] in gastrocnemious muscles injections in children with cerebral palsy: Randomized double-blind clinical trial.
abstract: BACKGROUND
  The only two preparations of botulinum toxin A for which there are published evidences of efficacy in children with cerebral palsy are onabotulinum toxin A (Botox(®)) and abobotulinum toxin A (Dyport(®)); these toxins should be considered generally safe and appropriate in the treatment for localized upper and lower limb spasticity.
  
  
  OBJECTIVE
  To establish the safety profile of incobotulinum toxin A (Xeomin(®)) in children with cerebral palsy and muscle spasticity.
  
  
  METHODS
  Randomized double-blind controlled trial that involved the recruitment of children of both sexes with spastic hemiplegia or diplegia in cerebral palsy, aged between 3 and 18 years. Children were randomized to either the study group (SG, incobotulinum toxin A) or the control group (CG, onabotulinum toxin A) both to be injected with 5units/kg on gastrocnemius (medialis and lateralis) muscles. The occurrence of adverse events at baseline, after 48 h, 10 days and 3 months was recorded by the caregivers in a checklist that listed both common and uncommon side effects.
  
  
  RESULTS
  35 patients were treated (CG = 18; SG = 17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within first 2 days, 46% between 2 and 10 days, and 12% between 10 and 90 days. All the reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups.
  
  
  CONCLUSIONS
  Incobotulinum toxin A and onabotulinum toxin A share similar profile of safety in the treatment of lower limb spasticity in CP children.
authors.affiliation: "E. Medea" Scientific Institute, Conegliano Research Centre, Conegliano, TV, Italy. Electronic address: elena.carraro@gmail.com.
authors.forename: Elena
authors.initials: E
authors.lastname: Carraro
authors.affiliation: "E. Medea" Scientific Institute, Conegliano Research Centre, Conegliano, TV, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Trevisi
authors.affiliation: "E. Medea" Scientific Institute, Conegliano Research Centre, Conegliano, TV, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Martinuzzi
mesh_terms: D000293:Adolescent; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000150:complications / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009128:Muscle Spasticity / Q000150:complications / Q000188:drug therapy*; D018482:Muscle, Skeletal; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA
keywords: Botulinum toxins type A; Cerebral palsy; Muscle spasticity; Pediatrics