PMID- 21087238 OWN - NLM STAT- MEDLINE DCOM- 20110324 LR - 20181201 IS - 1469-8749 (Electronic) IS - 0012-1622 (Linking) VI - 53 IP - 3 DP - 2011 Mar TI - Neuronox versus BOTOX for spastic equinus gait in children with cerebral palsy: a randomized, double-blinded, controlled multicentre clinical trial. PG - 239-44 LID - 10.1111/j.1469-8749.2010.03830.x [doi] AB - AIM: The aim of this study was to evaluate the efficacy and safety of a newly manufactured botulinum toxin, Neuronox, compared with BOTOX for the treatment of the spastic equinus gait in children with cerebral palsy. METHOD: A total of 127 children with cerebral palsy, aged 2 to 10 years, who presented at three university hospitals with spastic equinus gait were assessed for eligibility to participate in this double-blinded, randomized, controlled trial. Of the 119 eligible participants (mean age 4.33 y; SD 2.07; 76 males and 43 females; 79 with diplegia and 40 with hemiplegia), 57 were classified as Gross Motor Function Classification System level I, 29 as level II, and 33 as level III. Participants were randomly assigned to receive an injection of Neuronox (n=60) or BOTOX (n=59) to the calf muscles at a dose of 4U/kg for those with hemiplegia and 6U/kg for those with diplegia. Assessments were performed at baseline (V1) and at 4 (V2), 12 (V3), and 24 (V4) weeks after the intervention. The primary outcome measure was response rate at V3, with a positive response being defined as at least a 2-point increase in the Physicians' Rating Scale (PRS) score. The non-inferiority margin was set as -20% for the difference in the response rate. The secondary outcome measures included PRS score, passive range of motion (PROM) of the ankle and knee, and Gross Motor Function Measure 88 (GMFM-88). Any adverse events were investigated for safety implications. RESULTS: The response rate of the Neuronox group at V3 was not inferior to that of the BOTOX group (90% lower limit=-11.58%). There were significant improvements in PRS, PROM of ankle dorsiflexion, and GMFM scores at V2, V3, and V4 in both groups. The changes in PRS score were not statistically different between the two groups in serial evaluation (p=0.96). PROM of the ankle dorsiflexion increased without any significant difference between the two groups, either overall (p=0.56) or at each visit (V2, p=0.32; V3, p=0.66; V4, p=0.90). The increase in GMFM score in serial measurements were not significantly different between the two groups (p=0.16), whereas it was larger in the BOTOX group than in the Neuronox group at V2 and V4 (p=0.03 and 0.05 respectively). The frequency of adverse events was not significantly different between the two groups (p=0.97), and drug-related complications of Neuronox treatment were not addressed. INTERPRETATION: The outcomes of Neuronox, based on PRS, proved to be as effective and safe as those of BOTOX for the treatment of spasticity in individuals with cerebral palsy. CI - (c) The Authors. Journal compilation (c) Mac Keith Press 2010. FAU - Kim, Keewon AU - Kim K AD - Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Korea. FAU - Shin, Hyung-Ik AU - Shin HI FAU - Kwon, Bum Sun AU - Kwon BS FAU - Kim, Sang Jun AU - Kim SJ FAU - Jung, Il-Young AU - Jung IY FAU - Bang, Moon Suk AU - Bang MS LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20101118 PL - England TA - Dev Med Child Neurol JT - Developmental medicine and child neurology JID - 0006761 RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Botulinum Toxins, Type A/administration & dosage/adverse effects/*therapeutic use MH - Cerebral Palsy/complications/*physiopathology MH - Child MH - Child, Preschool MH - Double-Blind Method MH - Drug Administration Schedule MH - Equinus Deformity/*complications/etiology/physiopathology MH - Female MH - Gait Disorders, Neurologic/*drug therapy/etiology/physiopathology MH - Humans MH - Injections MH - Male MH - Motor Skills/drug effects MH - Neuromuscular Agents/administration & dosage/adverse effects/*therapeutic use MH - Range of Motion, Articular/*drug effects MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2010/11/23 06:00 MHDA- 2011/03/25 06:00 CRDT- 2010/11/20 06:00 PHST- 2010/11/20 06:00 [entrez] PHST- 2010/11/23 06:00 [pubmed] PHST- 2011/03/25 06:00 [medline] AID - 10.1111/j.1469-8749.2010.03830.x [doi] PST - ppublish SO - Dev Med Child Neurol. 2011 Mar;53(3):239-44. doi: 10.1111/j.1469-8749.2010.03830.x. Epub 2010 Nov 18.