Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, 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 (mean age 5.2 years, SD 2; 54% male)with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 19 degrees, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.

Estimation of botulinum toxin type A efficacy on spasticity and functional outcome in children with spastic cerebral palsy

“…The results correlate with previous similar reports [21][22][23] . In these studies measurement of spasticity, including PMR, was done using the method and in the same way as in our study by MAS, and such parameter of the evaluated study sample was presented as mean, referring to non qualitative characteristics.…”

AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial

“…Doses were chosen on the basis of previous clinical studies 12,13 and are specific to abobotulinumtoxinA. Because of proprietary differences in manufacturing and assay procedures, potency units for abobotulinumtoxinA are not interchangeable with other BoNT-A products.…”

The effects of botulinum toxin injection frequency on calf muscle growth in young children with spastic cerebral palsy: A 12-month prospective study

“…Controlled Introduction Intramuscular botulinum neurotoxin type-A (BoNT-A) injections result in a partial chemo-denervation of skeletal muscle [1] and are widely used in the management of focal spasticity in children with spastic cerebral palsy (CP) [2,3]. The use of BoNT-A in children with spastic type CP is not considered to be a stand-alone treatment [4], and when combined with physiotherapy and the use of orthoses, may have a small to moderate effect on improving gait outcomes [5,6] and functional capacity [7,8] during the pharmaceutically active period (*2-6 months). Clinically, repeated BoNT-A injections are believed to maintain the time that the BoNT-A is active within the target muscle and, therefore, delay muscle contracture more effectively, with the frequency of injection guided by clinical assessments.…”