Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy

Mauricio R. Delgado, Marcin Bonikowski, Jorge Carranza, Edward Dabrowski, Dennis Matthews, Barry Russman, Ann Tilton, Juan Carlos Velez, Anne Sophie Grandoulier, Philippe Picaut

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

This was a prospective, repeat-treatment, open-label study (NCT01251380) of abobotulinumtoxinA for the management of lower limb spasticity in children who had completed a double-blind study. Children (2-17 years) received injections into the gastrocnemius-soleus complex, and other distal and proximal muscles as required (maximum total dose per injection cycle: 30 U/kg or 1000U). A total of 216 of the 241 double-blind patients entered the extension study and 207 received ≥1 open label injection into the gastrocnemius-soleus; 17-24% of patients also had injections into the hamstrings. The most frequent adverse events were related to common childhood infections and the most frequent treatment-related adverse event was injection site pain (n = 10). There was no evidence of a cumulative effect on adverse events. Sustained significant clinical improvements in muscle tone (Modified Ashworth Scale), spasticity (Tardieu Scale), overall clinical benefit (Physicians Global Assessment), and goal attainment (Goal Attainment Scale) were also observed across treatment cycles.

Original languageEnglish (US)
Pages (from-to)1058-1064
Number of pages7
JournalJournal of Child Neurology
Volume32
Issue number13
DOIs
StatePublished - Nov 1 2017

Keywords

  • abobotulinumtoxinA
  • cerebral palsy
  • Dysport
  • equinus foot

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Clinical Neurology

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    Delgado, M. R., Bonikowski, M., Carranza, J., Dabrowski, E., Matthews, D., Russman, B., Tilton, A., Velez, J. C., Grandoulier, A. S., & Picaut, P. (2017). Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy. Journal of Child Neurology, 32(13), 1058-1064. https://doi.org/10.1177/0883073817729918