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

Pediatrics
Mauricio R DelgadoPhilippe Picaut

Abstract

Although botulinum toxin is a well-established treatment of focal spasticity in cerebral palsy, most trials have been small, and few have simultaneously assessed measures of muscle tone and clinical benefit. Global, randomized, controlled study to assess the efficacy and safety of abobotulinumtoxinA versus placebo in cerebral palsy children with dynamic equinus foot deformity. Patients were randomized (1:1:1) to abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injections into the gastrocnemius-soleus complex (1 or both legs injected). In the primary hierarchical analysis, demonstration of benefit for each dose required superiority to placebo on the primary (change in Modified Ashworth Scale from baseline to week 4) and first key secondary (Physician's Global Assessment at week 4) end points. Two hundred and forty-one patients were randomized, and 226 completed the study; the intention to treat population included 235 patients (98%). At week 4, Modified Ashworth Scale scores significantly improved with abobotulinumtoxinA; mean (95% confidence interval) treatment differences versus placebo were -0.49 (-0.75 to -0.23; P = .0002) for 15 U/kg/leg and -0.38 (-0.64 to -0.13; P = .003) for 10 U/kg/leg. The Physician's Global Ass...Continue Reading

Associated Clinical Trials

Citations

Jun 18, 2017·Paediatric Drugs·Yahiya Y Syed
Jul 14, 2017·Journal of Pediatric Orthopedics. Part B·Matthew LeePaula Kelly
Sep 16, 2017·Journal of Child Neurology·Mauricio R DelgadoPhilippe Picaut
May 29, 2018·Physiotherapy Research International : the Journal for Researchers and Clinicians in Physical Therapy·Dursun ErbilDursun Nigar
Jun 22, 2018·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·A P KovalenkoM A Koshkarev
Aug 4, 2018·Journal of Pediatric Orthopedics·Kishore MulpuriMininder S Kocher
Mar 5, 2019·World Journal of Pediatrics : WJP·Axel HorschMatthias Klotz
Oct 9, 2019·The Cochrane Database of Systematic Reviews·Francesco C BlumettiJosé A Pinto
Aug 16, 2019·JBJS Reviews·Iqbal MultaniH Kerr Graham
Jan 17, 2017·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·A L KurenkovТ А Belogorova
Aug 30, 2018·Journal of Children's Orthopaedics·T Hastings-IsonH K Graham
Jun 25, 2019·Journal of Managed Care & Specialty Pharmacy·Sonia PulgarChristine Ferro
Jan 1, 2019·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·S E KhatkovaA S Orlova
Jan 1, 2019·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·D A IskraD N Frunza
Oct 19, 2019·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·A P KovalenkoK A Sinelnikov
Jan 19, 2021·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·A L KurenkovKh M Karimova
Jan 8, 2021·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Stephen R Deputy, Ann H Tilton
Nov 19, 2020·Developmental Medicine and Child Neurology·Mauricio R DelgadoUNKNOWN Dysport in PUL study group
Jun 8, 2021·Journal of Pediatric Rehabilitation Medicine·Florian HeinenDeborah Gaebler-Spira

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