Abstract
BackgroundBotulinum 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 FindingsWe 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.ConclusionOur 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 RegistrationClinicalTrials.gov NCT00819065.
Highlights
Spasticity is a motor disorder characterized by a velocitydependent increase in tonic stretch reflex [1] that might cause pain and disability [2,3]
Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity
A total of 60 patients were randomized to the Botulinum toxin type A (btxA) treatments
Summary
Spasticity is a motor disorder characterized by a velocitydependent increase in tonic stretch reflex [1] that might cause pain and disability [2,3]. Botulinum toxin type A (btxA) is considered one of the main treatment choices for patients with spasticity irrespective the causes [3]. Two randomized clinical trials demonstrated similar effectiveness comparing ProsigneH and BotoxH in focal dystonia [7,8]. In this non-inferiority study, we analyzed the efficacy and safety of ProsigneH compared to BotoxH in patients with spasticity resultant from several causes. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity
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