Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity

A randomized, double blind, multi-center, phase III clinical trial

Kyung Hee Do, Min Ho Chun, Nam-Jong Paik, Yoon Ghil Park, Shi-Uk Lee, Min Wook Kim, Don Kyu Kim

Research output: Contribution to journalReview articleResearchpeer-review

3 Citations (Scopus)

Abstract

Objective: To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®). Design: A prospective, double-blinded, multicenter, randomized controlled clinical study. Setting: Six university hospitals in Korea. Subjects: A total of 187 stroke participants with upper limb spasticity. Interventions: Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)(P>0.05). Main measures: Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. Results: The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93(P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12,P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale (P<0.05), and no significant difference was observed between the two groups (P>0.05). In addition, safety measures showed no significant differences between the two groups (P>0.05). Conclusions: The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

Original languageEnglish
Pages (from-to)1179-1188
Number of pages10
JournalClinical Rehabilitation
Volume31
Issue number9
DOIs
StatePublished - 1 Sep 2017

Fingerprint

Phase III Clinical Trials
Upper Extremity
Stroke
Safety
Wrist
Type A Botulinum Toxins
Caregivers
Therapeutics
Vital Signs
Thumb
Korea
Elbow
Fingers
Physical Examination
onabotulinumtoxinA
Age Groups
Outcome Assessment (Health Care)
Injections

Keywords

  • botulinum neurotoxin type A
  • efficacy
  • safety
  • Spasticity
  • stroke

Cite this

@article{1c601b2563c14a1299087129dc1a6d37,
title = "Safety and efficacy of letibotulinumtoxinA(BOTULAX{\circledR}) in treatment of post stroke upper limb spasticity: A randomized, double blind, multi-center, phase III clinical trial",
abstract = "Objective: To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax{\circledR}) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox{\circledR}). Design: A prospective, double-blinded, multicenter, randomized controlled clinical study. Setting: Six university hospitals in Korea. Subjects: A total of 187 stroke participants with upper limb spasticity. Interventions: Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)(P>0.05). Main measures: Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. Results: The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93(P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95{\%} CI:-0.23-0.12,P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale (P<0.05), and no significant difference was observed between the two groups (P>0.05). In addition, safety measures showed no significant differences between the two groups (P>0.05). Conclusions: The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.",
keywords = "botulinum neurotoxin type A, efficacy, safety, Spasticity, stroke",
author = "Do, {Kyung Hee} and Chun, {Min Ho} and Nam-Jong Paik and Park, {Yoon Ghil} and Shi-Uk Lee and Kim, {Min Wook} and Kim, {Don Kyu}",
year = "2017",
month = "9",
day = "1",
doi = "10.1177/0269215516689331",
language = "English",
volume = "31",
pages = "1179--1188",
journal = "Clinical Rehabilitation",
issn = "0269-2155",
publisher = "SAGE Publications Ltd",
number = "9",

}

Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity : A randomized, double blind, multi-center, phase III clinical trial. / Do, Kyung Hee; Chun, Min Ho; Paik, Nam-Jong; Park, Yoon Ghil; Lee, Shi-Uk; Kim, Min Wook; Kim, Don Kyu.

In: Clinical Rehabilitation, Vol. 31, No. 9, 01.09.2017, p. 1179-1188.

Research output: Contribution to journalReview articleResearchpeer-review

TY - JOUR

T1 - Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity

T2 - A randomized, double blind, multi-center, phase III clinical trial

AU - Do, Kyung Hee

AU - Chun, Min Ho

AU - Paik, Nam-Jong

AU - Park, Yoon Ghil

AU - Lee, Shi-Uk

AU - Kim, Min Wook

AU - Kim, Don Kyu

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Objective: To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®). Design: A prospective, double-blinded, multicenter, randomized controlled clinical study. Setting: Six university hospitals in Korea. Subjects: A total of 187 stroke participants with upper limb spasticity. Interventions: Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)(P>0.05). Main measures: Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. Results: The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93(P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12,P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale (P<0.05), and no significant difference was observed between the two groups (P>0.05). In addition, safety measures showed no significant differences between the two groups (P>0.05). Conclusions: The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

AB - Objective: To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®). Design: A prospective, double-blinded, multicenter, randomized controlled clinical study. Setting: Six university hospitals in Korea. Subjects: A total of 187 stroke participants with upper limb spasticity. Interventions: Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)(P>0.05). Main measures: Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. Results: The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93(P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12,P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale (P<0.05), and no significant difference was observed between the two groups (P>0.05). In addition, safety measures showed no significant differences between the two groups (P>0.05). Conclusions: The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

KW - botulinum neurotoxin type A

KW - efficacy

KW - safety

KW - Spasticity

KW - stroke

UR - http://www.scopus.com/inward/record.url?scp=85027150032&partnerID=8YFLogxK

U2 - 10.1177/0269215516689331

DO - 10.1177/0269215516689331

M3 - Review article

VL - 31

SP - 1179

EP - 1188

JO - Clinical Rehabilitation

JF - Clinical Rehabilitation

SN - 0269-2155

IS - 9

ER -