Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy

Petr Kaňovský, Martin Bareš, Stanislav Severa, Alan Richardson, J. Kraus, S. Severa, A. C. Turconi, M. Bonikowski, M. Jasinski, M. Jozwiak, A. Lukaszewska, I. Tymecka-Maciag, J. Wendorff, J. Benetin, L. Lisý, E. Cardo, A. Macaya, S. I P Pascual, P. Poo, D. FontanR. Morton

Research output: Contribution to journalArticle

Abstract

In this study, we compared the long-term efficacy and tolerability of two dosage regimens of the potent botulinum toxin type A (BoNT-A; Dysport; Ipsen Ltd, Slough, UK) in children with cerebral palsy (CP) and lower-limb spasticity. Children aged 1 to 8 years with diplegic CP who were able to walk (aided or unaided) were randomized (1:1) to 30 LD 50 units/kg total body weight of BoNT-A (injected into gastrocnemius muscles) every 4 months or once yearly for 2 years in this multicentre, assessor-blinded, parallel-group study. In the 4-monthly group (n = 110, 39 males, 71 females), mean age was 3 years 8 months (SD 1y 6 mo, range 1-8 y). In the yearly group (n = 104, 47 males, 57 females), mean age was 4 years 4 months (SD 1y 6mo, range 2-8y). Both treatment groups had similar baseline Gross Motor Function Measure scores. At month 28 (primary endpoint; intention-to-treat group), median maximum passive ankle dorsiflexion was 12.00° in the 4-monthly and 11.00° in the yearly group. Between-group difference of 1.67° was not statistically significant (p = 0.055). Other efficacy endpoints showed no significant difference between the regimens. The results of the study do not allow a clear conclusion of the preferred injection regimen.

Original languageEnglish
Pages (from-to)436-445
Number of pages10
JournalDevelopmental Medicine and Child Neurology
Volume51
Issue number6
DOIs
Publication statusPublished - 2009

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ASJC Scopus subject areas

  • Clinical Neurology
  • Pediatrics, Perinatology, and Child Health
  • Developmental Neuroscience

Cite this

Kaňovský, P., Bareš, M., Severa, S., Richardson, A., Kraus, J., Severa, S., Turconi, A. C., Bonikowski, M., Jasinski, M., Jozwiak, M., Lukaszewska, A., Tymecka-Maciag, I., Wendorff, J., Benetin, J., Lisý, L., Cardo, E., Macaya, A., Pascual, S. I. P., Poo, P., ... Morton, R. (2009). Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy. Developmental Medicine and Child Neurology, 51(6), 436-445. https://doi.org/10.1111/j.1469-8749.2008.03264.x