Ann Rehabil Med.  2022 Aug;46(4):163-171. 10.5535/arm.22061.

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

• Hwang W
• Kang SM
• Lee SY
• Seo HG
• Park YG
• Kwon BS
• Lee KJ
• Kim DY
• Kim HS
• Lee SU

• KMID: 2532949
• DOI: http://doi.org/10.5535/arm.22061

Abstract

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.

Keyword

Stroke; Muscle spasticity; Botulinum toxin type A; Treatment efficacy; Safety; Clinical trial; Phase 4

Figure

• 

  Fig. 1 Flow chart showing the patient enrollment process.

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  Fig. 2 Modified Ashworth Scale (MAS) scores for the wrist, elbow, and finger flexor muscles at baseline and at 4, 8, and 12 weeks post-injection for the full analysis set. Values are shown as mean±standard deviation. ***p<0.001 (post-hoc Wilcoxon signed-rank test adjusted by Bonferroni correction).

• 

  Fig. 3 Disability Assessment Scale (DAS) score in each domain at baseline and at 4, 8, and 12 weeks post-injection for the full analysis set. Values are shown as the mean±standard deviation. **p<0.01, ***p<0.001 (post-hoc Wilcoxon signed-rank test adjusted by Bonferroni correction).

• 

  Fig. 4 Caregiver Burden Scale (CBS) score in each domain at baseline and at 4, 8, and 12 weeks post-injection for the full analysis set. Values are shown as the mean±standard deviation. *p<0.05, **p<0.01, ***p<0.001 (post-hoc Wilcoxon signed-rank test adjusted by Bonferroni correction).

• 

  Fig. 5 Global Assessment Scale (GAS) score rated by the physician or patient/caregiver at 12 weeks post-injection for the full analysis set.

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