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Efficacy and Safety of Botulinum Toxin Type A (NABOTA) for Post-stroke Upper Extremity Spasticity: A Multicenter Phase IV Trial

 Wonjae Hwang  ;  Seong Min Kang  ;  Sang Yoon Lee  ;  Han Gil Seo  ;  Yoon Ghil Park  ;  Bum Sun Kwon  ;  Kwang Jae Lee  ;  Deog Young Kim  ;  Hyoung Seop Kim  ;  Shi-Uk Lee 
 Annals of Rehabilitation Medicine, Vol.46(4) : 163-171, 2022-08 
Journal Title
Annals of Rehabilitation Medicine
Issue Date
Botulinum toxin type A ; Clinical trial ; Muscle spasticity ; Phase 4 ; Safety ; Stroke ; Treatment efficacy
Objective: To evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.

Methods: This prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.

Results: There was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.

Conclusion: NABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.
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1. College of Medicine (의과대학) > Dept. of Rehabilitation Medicine (재활의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Deog Young(김덕용) ORCID logo https://orcid.org/0000-0001-7622-6311
Park, Yoon Ghil(박윤길) ORCID logo https://orcid.org/0000-0001-9054-5300
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