title: Safety and efficacy of letibotulinumtoxinA(BOTULAX®) 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®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®).
  
  
  METHODS
  A prospective, double-blinded, multicenter, randomized controlled clinical study.
  
  
  METHODS
  Six university hospitals in Korea.
  
  
  METHODS
  A total of 187 stroke participants with upper limb spasticity.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors.affiliation: 1 Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Do
authors.affiliation: 2 Department of Physical Medicine and Rehabilitation, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Chun
authors.affiliation: 3 Department of Rehabilitation, Seoul National University College of Medicine, Seoul, Korea.|4 Department of Rehabilitation, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Nam-Jong
authors.initials: NJ
authors.lastname: Paik
authors.affiliation: 5 Department of Rehabilitation Medicine and Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yoon Ghil
authors.initials: YG
authors.lastname: Park
authors.affiliation: 3 Department of Rehabilitation, Seoul National University College of Medicine, Seoul, Korea.|6 Department of Physical Medicine and Rehabilitation, Seoul National University Boramae Medical Center, Seoul, Korea.
authors.forename: Shi-Uk
authors.initials: SU
authors.lastname: Lee
authors.affiliation: 7 Department of Physical Medicine and Rehabilitation, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.
authors.forename: Min-Wook
authors.initials: MW
authors.lastname: Kim
authors.affiliation: 8 Department of Physical Medicine and Rehabilitation, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Don-Kyu
authors.initials: DK
authors.lastname: Kim
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D011446:Prospective Studies; D056910:Republic of Korea; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D034941:Upper Extremity
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Spasticity; botulinum neurotoxin type A; efficacy; safety; stroke