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 (a...

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Bibliographic Details
Published in:Developmental medicine and child neurology 2009-06, Vol.51 (6), p.436-445
Main Authors: KAŇOVSKÝ, PETR, BAREŠ, MARTIN, SEVERA, STANISLAV, RICHARDSON, ALAN
Format: Article
Language:English
Subjects:
Body Weight
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - adverse effects
Cerebral Palsy
Cerebral Palsy - drug therapy
Child
Child, Preschool
Clinical Diagnosis
Coding
Contracture - surgery
Drug Administration Schedule
Female
Functional Behavioral Assessment
Gait
Humans
Infant
Leg
Male
Muscle Spasticity - drug therapy
Muscle, Skeletal
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - adverse effects
Patients
Physical Disabilities
Physicians
Referral
Surgery
Trauma Severity Indices
Treatment Outcome
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Summary: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 LD50 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 6mo, range 1–8y). 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.
ISSN:0012-1622
1469-8749
DOI:10.1111/j.1469-8749.2008.03264.x