Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins
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-f...
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| Format: | Article |
| Language: | English |
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MDPI AG
2015-12-01
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| Series: | Toxins |
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| Online Access: | http://www.mdpi.com/2072-6651/8/1/4 |
| _version_ | 1798035103008423936 |
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| author | Hyun-Mi Oh Joo Hyun Park Dae Heon Song Myung Eun Chung |
| author_facet | Hyun-Mi Oh Joo Hyun Park Dae Heon Song Myung Eun Chung |
| author_sort | Hyun-Mi Oh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T20:53:32Z |
| format | Article |
| id | doaj.art-3955977127ab4bafa39093568a247115 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-04-11T20:53:32Z |
| publishDate | 2015-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-3955977127ab4bafa39093568a2471152022-12-22T04:03:46ZengMDPI AGToxins2072-66512015-12-0181410.3390/toxins8010004toxins8010004Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing ProteinsHyun-Mi Oh0Joo Hyun Park1Dae Heon Song2Myung Eun Chung3Department of Rehabilitation Medicine, Seoul St. Mary‘s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, KoreaDepartment of Rehabilitation Medicine, Seoul St. Mary‘s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, KoreaDepartment of Rehabilitation Medicine, St. Paul‘s Hospital, College of Medicine, The Catholic University of Korea, Wangsan-ro 180, Dongdaemoon-Gu, Seoul 02559, KoreaDepartment of Rehabilitation Medicine, St. Paul‘s Hospital, College of Medicine, The Catholic University of Korea, Wangsan-ro 180, Dongdaemoon-Gu, Seoul 02559, KoreaMT10107 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.http://www.mdpi.com/2072-6651/8/1/4botulinumtoxinstype Aefficacysafetyclinical trial |
| spellingShingle | Hyun-Mi Oh Joo Hyun Park Dae Heon Song Myung Eun Chung Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins Toxins botulinumtoxins type A efficacy safety clinical trial |
| title | Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins |
| title_full | Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins |
| title_fullStr | Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins |
| title_full_unstemmed | Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins |
| title_short | Efficacy and Safety of a New Botulinum Toxin Type A Free of Complexing Proteins |
| title_sort | efficacy and safety of a new botulinum toxin type a free of complexing proteins |
| topic | botulinumtoxins type A efficacy safety clinical trial |
| url | http://www.mdpi.com/2072-6651/8/1/4 |
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