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 Chun, Hea Eun Yang, Dae Hyun Kim, Youbin Yi, Han Gil Seo, Kwang Dong Kim, Min Cheol Chang, Jae Hak Ryu, Shi Uk Lee

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks 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.

Original languageEnglish
Pages (from-to)192-197
Number of pages6
JournalJournal of the Neurological Sciences
Volume357
Issue number1-2
DOIs
StatePublished - 9 May 2015

Fingerprint

Upper Extremity
Randomized Controlled Trials
Stroke
Safety
Wrist
Type A Botulinum Toxins
Caregivers
Injections
Muscles
Thumb
Elbow
Fingers
Outcome Assessment (Health Care)
onabotulinumtoxinA
Confidence Intervals
Pharmaceutical Preparations

Keywords

  • Botulinum toxin A
  • Efficacy
  • Safety
  • Spasticity
  • Stroke
  • Upper limb

Cite this

Nam, Hyung Seok ; Park, Yoon Ghil ; Paik, Nam Jong ; Oh, Byung Mo ; Chun, Min Ho ; Yang, Hea Eun ; Kim, Dae Hyun ; Yi, Youbin ; Seo, Han Gil ; Kim, Kwang Dong ; Chang, Min Cheol ; Ryu, Jae Hak ; Lee, Shi Uk. / Efficacy and safety of NABOTA in post-stroke upper limb spasticity : A phase 3 multicenter, double-blinded, randomized controlled trial. In: Journal of the Neurological Sciences. 2015 ; Vol. 357, No. 1-2. pp. 192-197.
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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 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks 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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Efficacy and safety of NABOTA in post-stroke upper limb spasticity : A phase 3 multicenter, double-blinded, randomized controlled trial. / Nam, Hyung Seok; Park, Yoon Ghil; Paik, Nam Jong; Oh, Byung Mo; Chun, Min Ho; Yang, Hea Eun; Kim, Dae Hyun; Yi, Youbin; Seo, Han Gil; Kim, Kwang Dong; Chang, Min Cheol; Ryu, Jae Hak; Lee, Shi Uk.

In: Journal of the Neurological Sciences, Vol. 357, No. 1-2, 09.05.2015, p. 192-197.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of NABOTA in post-stroke upper limb spasticity

T2 - A phase 3 multicenter, double-blinded, randomized controlled trial

AU - Nam, Hyung Seok

AU - Park, Yoon Ghil

AU - Paik, Nam Jong

AU - Oh, Byung Mo

AU - Chun, Min Ho

AU - Yang, Hea Eun

AU - Kim, Dae Hyun

AU - Yi, Youbin

AU - Seo, Han Gil

AU - Kim, Kwang Dong

AU - Chang, Min Cheol

AU - Ryu, Jae Hak

AU - Lee, Shi Uk

PY - 2015/5/9

Y1 - 2015/5/9

N2 - 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 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks 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.

AB - 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 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks 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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KW - Efficacy

KW - Safety

KW - Spasticity

KW - Stroke

KW - Upper limb

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