title: Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial.
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 4weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12weeks. The change of MAS for wrist flexor between baseline and 4weeks 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.
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Department of Biomedical Engineering, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hyung Seok
authors.initials: HS
authors.lastname: Nam
authors.affiliation: Department of Rehabilitation Medicine and Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yoon Ghil
authors.initials: YG
authors.lastname: Park
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Nam-Jong
authors.initials: NJ
authors.lastname: Paik
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Byung-Mo
authors.initials: BM
authors.lastname: Oh
authors.affiliation: Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Chun
authors.affiliation: Department of Rehabilitation Medicine and Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hea-Eun
authors.initials: HE
authors.lastname: Yang
authors.affiliation: Department of Rehabilitation Medicine and Rehabilitation Institute of Neuromuscular Disease, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Youbin
authors.initials: Y
authors.lastname: Yi
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Han Gil
authors.initials: HG
authors.lastname: Seo
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Kwang Dong
authors.initials: KD
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Department of Physical Medicine and Rehabilitation, Union Hospital, Daegu, Republic of Korea.
authors.forename: Min Cheol
authors.initials: MC
authors.lastname: Chang
authors.affiliation: Clinical Research Team, Daewoong Pharmaceutical, Seoul, Republic of Korea.
authors.forename: Jae Hak
authors.initials: JH
authors.lastname: Ryu
authors.affiliation: Department of Rehabilitation Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: shiuk.lee@gmail.com.
authors.forename: Shi-Uk
authors.initials: SU
authors.lastname: Lee
mesh_terms: D000368:Aged; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D018908:Muscle Weakness / Q000139:chemically induced; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020521:Stroke / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000473:pathology
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Botulinum toxin A; Efficacy; Safety; Spasticity; Stroke; Upper limb