A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity.
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 spasticit...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2013-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC3585303?pdf=render |
| _version_ | 1818313642190307328 |
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| author | Fábio Coelho Guarany Paulo Dornelles Picon Nicole Ruas Guarany Antonio Cardoso dos Santos Bianca Paula Mentz Chiella Carolina Rocha Barone Lúcia Costa Cabral Fendt Pedro Schestatsky |
| author_facet | Fábio Coelho Guarany Paulo Dornelles Picon Nicole Ruas Guarany Antonio Cardoso dos Santos Bianca Paula Mentz Chiella Carolina Rocha Barone Lúcia Costa Cabral Fendt Pedro Schestatsky |
| author_sort | Fábio Coelho Guarany |
| collection | DOAJ |
| description | 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.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.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.ClinicalTrials.gov NCT00819065. |
| first_indexed | 2024-12-13T08:36:59Z |
| format | Article |
| id | doaj.art-5cc03012fcdd4a3b98471f349749b62d |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-13T08:36:59Z |
| publishDate | 2013-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-5cc03012fcdd4a3b98471f349749b62d2022-12-21T23:53:37ZengPublic Library of Science (PLoS)PLoS ONE1932-62032013-01-0182e5647910.1371/journal.pone.0056479A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity.Fábio Coelho GuaranyPaulo Dornelles PiconNicole Ruas GuaranyAntonio Cardoso dos SantosBianca Paula Mentz ChiellaCarolina Rocha BaroneLúcia Costa Cabral FendtPedro SchestatskyBotulinum 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.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.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.ClinicalTrials.gov NCT00819065.http://europepmc.org/articles/PMC3585303?pdf=render |
| spellingShingle | Fábio Coelho Guarany Paulo Dornelles Picon Nicole Ruas Guarany Antonio Cardoso dos Santos Bianca Paula Mentz Chiella Carolina Rocha Barone Lúcia Costa Cabral Fendt Pedro Schestatsky A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. PLoS ONE |
| title | A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. |
| title_full | A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. |
| title_fullStr | A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. |
| title_full_unstemmed | A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. |
| title_short | A double-blind, randomised, crossover trial of two botulinum toxin type a in patients with spasticity. |
| title_sort | double blind randomised crossover trial of two botulinum toxin type a in patients with spasticity |
| url | http://europepmc.org/articles/PMC3585303?pdf=render |
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