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

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...

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Bibliographic Details
Published in:Annals of rehabilitation medicine 2022, 46(4), , pp.163-171
Main Authors: Hwang, Wonjae, Kang, Seong Min, Lee, Sang Yoon, Seo, Han Gil, Park, Yoon Ghil, Kwon, Bum Sun, Lee, Kwang Jae, Kim, Deog Young, Kim, Hyoung Seop, Lee, Shi-Uk
Format: Article
Language:English
Subjects:
botulinum toxin type a
clinical trial
muscle spasticity
Original
phase 4
safety
stroke
treatment efficacy
재활의학
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Summary: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
ISSN:2234-0645
2234-0653
DOI:10.5535/arm.22061