Spasticity - Clinical Trials of Botulinum Toxin Type A in the Treatment of Spasticity

Spasticity

Clinical Trials of Botulinum Toxin Type A in the Treatment of Spasticity

Clinical trials of Botulinum Toxin in the Treatment of Spasticity
David M. Simpson, MD
MF Brin, MD, editor
Muscle Nerve 1997; 20 (suppl 6): S169-S175.

Abstract: Botulinum toxin type A 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.

Key Points:

Botulinum toxin type A has been used in clinical trials for spasticity from MS, CP, TBI, SCI, and stroke

Multiple sclerosis: Injection of 400 U of BTX-A (BOTOX®) into the thigh adductors resulted in significant improvement in spasticity and hygiene vs. placebo (Snow et al.)

Spinal cord injury: Injection of 20-80 U of BTX-A (BOTOX®) into the rhabdosphincter resulted in decreased urethral pressure and post-void residual volume (Dykstra et al.)

Cerebral palsy: Injection of 1.0 U/kg of BTX-A (BOTOX®) into the medial and lateral gastrocnemius of each leg resulted in an improvement in gait pattern vs. placebo (Koman et al.)

Stroke: Injection of 75-300 U of BTX-A (BOTOX®) into the elbow and wrist flexors resulted in significant improvement in the Ashworth scale vs. placebo (Simpson et al.)

Scales of global function are unlikely to detect the focal changes to be expected from BTX-A injections

Future trials of BTX-A may be improved by attention to dose-effect response, dose escalation, broader randomization, and more uniform timing of injection vs. onset of neurologic deficit

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