title: Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins.
abstract: MT10107 is botulinum neurotoxin type A derived drug which utilizes the 150 kDa portion without complexing proteins and human serum albumin contents. To evaluate the efficacy and the safety of MT10107, it was compared with onabotulinumtoxinA in this double-blind, randomized controlled trial. Twenty-five healthy males received a randomly selected dose of MT10107 into the extensor digitorum brevis (EDB) muscle of one foot, and an equivalent dose of onabotulinumtoxinA (BOTOX) was injected into the contralateral EDB muscle. While efficacy of the administered substance was determined by measuring paretic effects on the EDB, the local spread of toxin effects was evaluated by the paretic effects on the nearby abductor hallucis (AH) and abductor digiti quinti (ADQ) muscles. Paretic effects were defined as the percentage of reduction of the compound muscle action potential (CMAP) amplitudes, measured at 14, 30, 90 days after the injection, compared to the baseline value. Intergroup (MT10107 and onabotulinumtoxinA) differences were not significant in the percentage reduction of the amplitudes in the EDB muscles. In this study, there was no significant difference in efficacy and safety between the two test drugs. MT10107 may be effective and safe as much as onabotulinumtoxinA to produce the desired paretic effect.
authors.affiliation: Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea. hazel@cmcnu.or.kr.
authors.forename: Hyun-Mi
authors.initials: HM
authors.lastname: Oh
authors.affiliation: Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea. drpjh@catholic.ac.kr.
authors.forename: Joo Hyun
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Rehabilitation Medicine, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Wangsan-ro 180, Dongdaemoon-Gu, Seoul 02559, Korea. greatsong@catholic.ac.kr.
authors.forename: Dae Heon
authors.initials: DH
authors.lastname: Song
authors.affiliation: Department of Rehabilitation Medicine, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Wangsan-ro 180, Dongdaemoon-Gu, Seoul 02559, Korea. coltrane@catholic.ac.kr.
authors.forename: Myung Eun
authors.initials: ME
authors.lastname: Chung
mesh_terms: D000200:Action Potentials / Q000187:drug effects; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000494:pharmacology*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000502:physiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019274:Botulinum Toxins, Type A
keywords: botulinumtoxins; clinical trial; efficacy; safety; type A