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

 Hyung Seok Nam  ;  Yoon Ghil Park  ;  Nam Jong Paik  ;  Byung Mo Oh  ;  Min Ho Chung  ;  Hea Eun Yang  ;  Dae Hyun Kim  ;  Youbin Yi  ;  Han Gil Seo  ;  Kwang Dong Kim  ;  Min Cheol Chang  ;  Jae Hak Ryu  ;  Shi Uk Lee 
 JOURNAL OF THE NEUROLOGICAL SCIENCES, Vol.357(1-2) : 192-197, 2015 
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Aged ; Botulinum Toxins, Type A/adverse effects ; Botulinum Toxins, Type A/therapeutic use* ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Muscle Spasticity/diagnosis ; Muscle Spasticity/drug therapy* ; Muscle Spasticity/etiology ; Muscle Weakness/chemically induced ; Neuromuscular Agents/adverse effects ; Neuromuscular Agents/therapeutic use* ; Prospective Studies ; Stroke/complications ; Stroke/diagnosis ; Stroke/drug therapy* ; Treatment Outcome ; Upper Extremity*/pathology
Botulinum toxin A ; Efficacy ; Safety ; Spasticity ; Stroke ; Upper limb
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.
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1. College of Medicine (의과대학) > Dept. of Rehabilitation Medicine (재활의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Dae Hyun(김대현)
Park, Yoon Ghil(박윤길) ORCID logo https://orcid.org/0000-0001-9054-5300
Yang, Hye Eun(양혜은)
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