Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy.
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 1 y 6 mo, range 1-8 y). In the yearly group (n=104, 47 males, 57 females), mean age was 4 years 4 months (SD 1 y 6 mo, range 2-8 y). 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 degrees in the 4-monthly and 11.00 degrees in the yearly group. Between-group difference of 1.67 degrees 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.
Kanovský
Petr
P
1st Department of Neurology, Masaryk University, St Anne University Hospital, Brno, Czech Republic. petr.kanovsky@fnol.cz
Bares
Martin
M
Severa
Stanislav
S
Richardson
Alan
A
D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D002547:Cerebral Palsy / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003286:Contracture / Q000601:surgery; D004334:Drug Administration Schedule; D005260:Female; D005684:Gait; D006801:Humans; D007223:Infant; D007866:Leg; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy*; D018482:Muscle, Skeletal; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015599:Trauma Severity Indices; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A