Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

Abstract

BackgroundBotulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity.ObjectiveWe evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity.Methods In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit.Results Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12.Conclusion Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity.Trial RegistrationClinicalTrials.gov NCT01313767

Impact of Neu-botulinumtoxinA on the Severity and Quality of Life of Cervical Dystonia Patients

“…It has been shown to be non-inferior to onabotulinumtoxinA (Ona-BTX, BotoxH) in the treatment of blepharospam, moderate to severe glabellar lines, post-stroke upper limb spasticity, and spastic equinus gait in children with cerebral palsy. [12][13][14][15][16] Its cost is lower than Ona-BTX and abobotulinumtoxinA (Abo-BTX, DysportH) by approximately 10-30%.…”

Botulinum Toxin Type A Injection for Cervical Dystonia in Adults with Dyskinetic Cerebral Palsy

“…The BoNT-A used in this study was Neuronox ® , also known in Korea as Meditoxin ® (Medytox Inc., Ochang-eup, Cheong-won-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea). Neuronox ® and Meditoxin ® are equivalent to BOTOX [ 32 ] and have been found to be safe with similar efficacy as has been proven in previous studies in children with CP [ 33 ] and in stroke patients [ 34 ]. Electromyography was used to record the hyperactivity of the muscle to be injected before starting the injection.…”

Botulinum toxin treatment of lower extremity spasticity

“…Медикаметозное лечение спастич-ности пероральными препаратами (баклофен, тизани-дин, мидокалм, дантролен, диазепам) показано при ее генерализованном варианте, в случае же возникнове-ния фокального повышения мышечного тонуса эф-фективность использования пероральных миорелак-сантов невысока [17]. В этой ситуации препаратом выбора является ботулинический токсин типа А (БТА), имеющий высокий уровень доказательности [18,19]. Результаты многочисленных исследований продемон-стрировали его безопасность и эффективность в лече-нии фокальной спастичности [20,21].…”