Ontology highlight
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.Methodology/principal findings
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.Conclusion
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.Trial registration
ClinicalTrials.gov NCT00819065.
SUBMITTER: Guarany FC
PROVIDER: S-EPMC3585303 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
Guarany Fábio Coelho FC Picon Paulo Dornelles PD Guarany Nicole Ruas NR dos Santos Antonio Cardoso AC Chiella Bianca Paula Mentz BP Barone Carolina Rocha CR Fendt Lúcia Costa Cabral LC Schestatsky Pedro P
PloS one 20130228 2
<h4>Background</h4>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.<h4>Methodology/principal findings</h4>We performed ...[more]