Botulinum toxin treatment of spasticity in diplegic cerebral palsy : a randomised, double-blind, placebo-controlled, dose-ranging study

Abstract

This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport®) in 125 patients (meanage 5.2 years, SD 2; 54% male)with dynamic equinusspasticity during walking. Participants were randomized toreceive Dysport (10, 20, or 30 units/kg) or placebo to thegastrocnemius muscle of both legs. Muscle length wascalculated from electrogoniometric measurements and thechange in the dynamic component of gastrocnemiusshortening at four weeks was prospectively identified as theprimary outcome measure. All treatment groups showedstatistically significant decreases in dynamic componentcompared with placebo at 4 weeks. Mean improvement indynamic component was most pronounced in the 20 units/kggroup, being equivalent to an increase in dorsiflexion with the knee extended at 19°, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory