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Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial

Authors
 Hyung Seok Nam ; Yoon Ghil Park ; Shi Uk Lee ; Jae Hak Ryu ; Min Cheol Chang ; Kwang Dong Kim ; Han Gil Seo ; Youbin Yi ; Dae Hyun Kim ; Hea Eun Yang ; Min Ho Chung ; Byung Mo Oh ; Nam Jong Paik 
Citation
 Journal of the Neurological Sciences, Vol.357(1-2) : 192~197, 2015 
Journal Title
 Journal of the Neurological Sciences 
ISSN
 0022-510X 
Issue Date
2015
Abstract
Botulinum toxin A is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A). A total of 197 patients with post-stroke upper limb spasticity were included in this study and randomly assigned to NABOTA group (n=99) or Botox group (n=98). Wrist flexors with modified Ashworth Scale (MAS) grade 2 or greater, and elbow flexors, thumb flexors and finger flexors with MAS 1 or greater were injected with either drug. The primary outcome was the change of wrist flexor MAS between baseline and 4weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12weeks. The change of MAS for wrist flexor between baseline and 4weeks post-injection was -1.44±0.72 in the NABOTA group and -1.46±0.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval -0.2062-0.2319), within the non-inferiority margin of 0.45. Both groups showed significant improvements regarding MAS of all injected muscles, DAS, and Caregiver Burden Scale at all follow-up periods. There were no significant differences in all secondary outcome measures between the two groups. NABOTA demonstrated non-inferior efficacy and safety for improving upper limb spasticity in stroke patients compared to Botox.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/141561
DOI
10.1016/j.jns.2015.07.028
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Rehabilitation Medicine
Yonsei Authors
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Link
 http://www.sciencedirect.com/science/article/pii/S0022510X15004499
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