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Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study

Published online by Cambridge University Press:  10 October 2002

R Baker ,
M Jasinski ,
I Maciag-Tymecka ,
J Michalowska-Mrozek ,
M Bonikowski ,
L Carr ,
J MacLean ,
J-P Lin ,
B Lynch  and
T Theologis
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R Baker
Affiliation:
Musgrave Park Hospital, Belfast, Northern Ireland.
M Jasinski
Affiliation:
Dzieciecy Szpital Kliniczny AM W Lublinie, Lublin, Poland.
I Maciag-Tymecka
Affiliation:
Wojewodzki Oddzial Rehabilitacji Dzieci I Mlodziezy, Gdansk, Poland.
J Michalowska-Mrozek
Affiliation:
Instytut Pomnik-Centrum Zdrowia Dziecka, Warszawa, Poland.
M Bonikowski
Affiliation:
Dzial Neurologii Dzieciecy Swzpznoz, Zagórze, k/Warsawy, Poland.
L Carr
Affiliation:
The Wolfson Centre, Great Ormond Street Hospital for Sick Children NHS Trust, London, UK.
J MacLean
Affiliation:
Dundee Teaching Hospitals NHS Trust Hospital, Dundee, UK.
J-P Lin
Affiliation:
Newcomen Centre, Guy's & St Thomas' Hospital Trust, London, UK.
B Lynch
Affiliation:
Central Remedial Clinic, Dublin, Ireland.
T Theologis
Affiliation:
Nuffield Orthopaedic NHS Trust, Oxford, UK.
J Wendorff
Affiliation:
Centrum Zdrowia Matki Polki, Lódż, Poland.
P Eunson
Affiliation:
Edinburgh Sick Children's NHS Trust, Edinburgh, UK.
A Cosgrove
Affiliation:
Musgrave Park Hospital, Belfast, Northern Ireland.
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Abstract

This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport®) in 125 patients (mean age 5.2 years, SD 2; 54% male)with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 19°, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.

Type
Original Articles
Information
Developmental Medicine and Child Neurology , Volume 44 , Issue 10 , October 2002 , pp. 666 - 675
Copyright
© 2002 Mac Keith Press

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