title: Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial.
abstract: BACKGROUND
  Botulinum 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.
  
  
  OBJECTIVE
  We 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.
  
  
  CONCLUSIONS
  Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01313767.
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Han Gil
authors.initials: HG
authors.lastname: Seo
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Nam-Jong
authors.initials: NJ
authors.lastname: Paik
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Shi-Uk
authors.initials: SU
authors.lastname: Lee
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Byung-Mo
authors.initials: BM
authors.lastname: Oh
authors.affiliation: Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Chun
authors.affiliation: Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Bum Sun
authors.initials: BS
authors.lastname: Kwon
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Moon Suk
authors.initials: MS
authors.lastname: Bang
mesh_terms: D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000473:pathology*
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A