TY - JOUR
T1 - Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy
AU - Kaňovský, Petr
AU - Bareš, Martin
AU - Severa, Stanislav
AU - Richardson, Alan
AU - Kraus, J.
AU - Severa, S.
AU - Turconi, A. C.
AU - Bonikowski, M.
AU - Jasinski, M.
AU - Jozwiak, M.
AU - Lukaszewska, A.
AU - Tymecka-Maciag, I.
AU - Wendorff, J.
AU - Benetin, J.
AU - Lisý, L.
AU - Cardo, E.
AU - Macaya, A.
AU - Pascual, S. I P
AU - Poo, P.
AU - Fontan, D.
AU - Morton, R.
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
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U2 - 10.1111/j.1469-8749.2008.03264.x
DO - 10.1111/j.1469-8749.2008.03264.x
M3 - Article
C2 - 19563586
AN - SCOPUS:65549158884
VL - 51
SP - 436
EP - 445
JO - Developmental Medicine and Child Neurology
JF - Developmental Medicine and Child Neurology
SN - 0012-1622
IS - 6
ER -