High dose of botulinum toxin type-A (BTX/A): safety and efficacy in patients with cerebral palsy

Cerebral palsy (CP) is a severely debilitating condition. The underlying insult results in irreversible damage to the central nervous system, treatment is essentially palliative. Botulinum toxin type-A (BTX/A) Botox® Allergan, Inc. injections have been found to be effective palliation for dynamic spasticity in CP. There is a paucity of data regarding the maximum dose tolerated in the pediatric population. The present study examines the safety and efficacy of BTX/A therapy at up to 40 U/kg. Twenty-two patients were treated from 1995 to 1999. The population included four adults and 18 pediatric patients. Patients were in three groups: diplegia (n=12), hemiplegia (n=5), and quadriplegia (n=5). They were evaluated by the Modified Ashworth Scale. The incidence and severity of complications is also reported. The significance of these data is also commented upon. This study suggests that BTX/A therapy is safe, efficacious, and cost effective at higher doses, and should be considered as part of a comprehensive therapeutic regimen in appropriate candidates. (J Pediatr Neurol 2004; 2(2): 91-96).