Clinical trials of botulinum toxin in the treatment of spasticity.

Botulinum toxin has been tested as a treatment for spasticity resulting from cerebral palsy, multiple sclerosis, traumatic brain injury, spinal cord injury, and stroke. The results of 18 studies are reviewed in this article. In both open label and double-blind, placebo-controlled trials, botulinum toxin has proven to be an effective measure for reduction of focal spasticity. Improvements have been documented in tone reduction, range of motion, hygiene, autonomic dysreflexia, gait pattern, positioning, and other criteria, though not all criteria tested showed improvement in all studies. In none of the studies were there significant adverse effects. Future trials may be improved by refinement of several design parameters, including patient selection, treatment timing, and selection of dose and injection site.