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Randomized Controlled Trial
. 2017 Apr;32(5):482-487.
doi: 10.1177/0883073816686910. Epub 2017 Jan 9.

AbobotulinumtoxinA (Dysport®) Improves Function According to Goal Attainment in Children With Dynamic Equinus Due to Cerebral Palsy

Affiliations
Randomized Controlled Trial

AbobotulinumtoxinA (Dysport®) Improves Function According to Goal Attainment in Children With Dynamic Equinus Due to Cerebral Palsy

Ann Tilton et al. J Child Neurol. 2017 Apr.

Abstract

This secondary analysis of a large (n = 241), randomized, double-blind study evaluated the efficacy of 2 doses of abobotulinumtoxinA + standard of care (SOC) versus placebo + SOC in enabling children with dynamic equinus due to cerebral palsy to achieve their functional goals using Goal Attainment Scaling. Most parents/caregivers selected goals targeting aspects of gait improvement as most relevant. Mean (95% confidence interval) Goal Attainment Scaling T scores at week 4 were higher for both abobotulinumtoxinA groups versus placebo (treatment difference vs placebo: 10 U/kg/leg: 5.32 [2.31, 8.32], P = .0006, and 15 U/kg/leg 4.65 [1.59, 7.71], P = .0031). Superiority of both abobotulinumtoxinA doses versus placebo was maintained at week 12. Best goal attainment T scores were higher in the abobotulinumtoxinA groups versus placebo for the common goals of improved walking pattern, decreased falling, decreased tripping, and improved endurance. These findings demonstrate that single injections of abobotulinumtoxinA (10 and 15 U/kg/leg) significantly improved the ability of pediatric cerebral palsy patients to achieve their functional goals.

Keywords: Dysport; abobotulinumtoxinA; cerebral palsy; equinus foot; goal attainment scaling.

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Conflict of interest statement

Declaration of Conflicting Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors (external from Ipsen) have been investigators in Ipsen-sponsored clinical trials (including the current study), and they or their institutions have received payment for participation. In addition, ATil reports personal fees from Ipsen for consultancy. BR reports receiving research support from Ipsen and honoraria from Ipsen for serving on advisory boards. RA, SK, and JCV have received research grant support from Ipsen. ATse was employed by Ipsen at the time of the study. ASG and PP are employed by Ipsen.

Figures

Figure 1.
Figure 1.
GAS T scores at weeks 4 and 12. Columns represent adjusted mean (95% confidence interval) GAS T scores. Adjusted LS Means were obtained from an analysis of covariance on the change from baseline with treatment, baseline score, age range at baseline, botulinum toxin status at baseline, and center as covariates. ABO, abobotulinumtoxinA; GAS, Goal Attainment Scaling; TE, adjusted LS mean (95% confidence interval) treatment effect versus placebo.

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