High doses of a new botulinum toxin type A (NT-201) in adult patients with severe spasticity following brain injury and cerebral palsy

Abstract

Background: Spasticity can be a severe disabling disorder requiring high-dose injections of botulinum toxin type A (BoNT-A). Efficacy and safety of high BoNT-A doses in reducing multi-level spasticity of subjects with brain injury and cerebral palsy were investigated. Pain and functional outcome were also assessed.

Method: High doses (up to 840 IU) of incobotulinumtoxinA were injected in adult subjects with severe spasticity of the upper and lower limbs due to brain injury (BI) and cerebral palsy (CP). The Modified Ashworth Scale, Visual Analogue scale, Glasgow Outcome Scale, Franchay Arm Test (FAT) and Barthel Scale were employed to assess spasticity, pain and functional outcome at baseline, and 4 and 16 weeks after BoNT-A injection.

Results: Twenty-two (12 M, 10 F; mean age 38.1 ± 13.7 years) subjects - 16 subjects with BI and 6 with CP - were enrolled. Elbow, wrist, fingers and ankle muscles showed significant spasticity reduction after BoNT-A injections. The mean FAT score improved, but the benefit was not significant. Three (13.6%) subjects complained of mild adverse events.

Conclusion: High-dose BoNT-A injections were effective and safe in reducing spasticity of BI and CP subjects. A significant reduction of the pain was also observed, but global functionality and arm dexterity were unchanged.

Keywords: Botulinum toxin; brain injury; cerebral palsy; efficacy; high dose; spasticity.