title: A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity.
abstract: BACKGROUND
  Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. Prosigne® a new released botulinum toxin serotype A may have the same effectiveness as Botox® in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of Prosigne® with Botox® in the treatment of spasticity.
  
  
  RESULTS
  We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after Prosigne® or Botox® administration. The main outcomes were changes in the patients' Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the Prosigne® and Botox® treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups.
  
  
  CONCLUSIONS
  Our results suggest that Prosigne® and Botox® are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00819065.
authors.affiliation: Physical Medicine and Rehabilitation Service, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil. fguarany@hotmail.com
authors.forename: Fábio Coelho
authors.initials: FC
authors.lastname: Guarany
authors.forename: Paulo Dornelles
authors.initials: PD
authors.lastname: Picon
authors.forename: Nicole Ruas
authors.initials: NR
authors.lastname: Guarany
authors.forename: Antonio Cardoso
authors.initials: AC
authors.lastname: dos Santos
authors.forename: Bianca Paula Mentz
authors.initials: BP
authors.lastname: Chiella
authors.forename: Carolina Rocha
authors.initials: CR
authors.lastname: Barone
authors.forename: Lúcia Costa Cabral
authors.initials: LC
authors.lastname: Fendt
authors.forename: Pedro
authors.initials: P
authors.lastname: Schestatsky
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D019274:Botulinum Toxins, Type A; C556222:prosigne