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Efficacy and Safety of Botulinum Toxin Type A in treating Lower Limb Spasticity in Post-stroke Patients : A Multicenter, Double-blind, Placebo-controlled Trial followed by an Open-label Trial Akio Kimura 1 , Masahiro Abo 2 , Nobuyuki Kawate 3 , Yuka Osako 4 , Kazuaki Suyama 4 , Toshio Maeda 4 , Yasuyuki Uechi 4 , Masaru Iwasaki 4 1Department of Rehabilitation Medicine, Keio University Tsukigase Rehabilitation Center 2Department of Rehabilitation Medicine, The Jikei University School of Medicine 3Department of Rehabilitation Medicine, Showa University Hospital 4Japan Development and Medical Affairs Division, GlaxoSmithKline K.K. Keyword: ボツリヌス毒素(botulinum toxin) , 痙縮(spasticity) , Modified Ashworth Scale , 下肢(lower limb) , 無作為化比較試験(randomized-controlled trial) pp.626-636
Published Date 2010/9/18
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Abstract Objective : To evaluate the efficacy and safety of botulinum toxin type A (BTXA) in Japanese patients with post-stroke lower limb spasticity in a multicenter, randomized, double-blind, single dose, placebo-controlled study (double-blind phase) followed by an open-label, multiple dose extension (open-label phase). Methods : One hundred and twenty patients with lower limb spasticity were randomized to receive a single treatment with BTXA 300 Units (U) or placebo into lower limb muscles in the double-blind phase. Patients who met the re-injection criteria received up to 3 repeated treatments of BTXA into lower limb muscles with at least 12 weeks between treatments in the open-label phase through 48 weeks. Results : In the double-blind phase there was significant improvement from baseline spasticity in the Modified Ashworth Scale (MAS) ankle score between the BTXA 300U and placebo groups, with a mean difference in the area under the curve (AUC) of -3.428 (p=0.006, t test). The MAS ankle score further decreased from baseline in all repeat treatment cycles of BTXA in the open-label phase. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BTXA-treated and placebo-treated patients during the study period. Conclusions : BTXA reduced spasticity in lower limb muscles from the first treatment with continued long-term efficacy. BTXA is safe and effective for the long-term treatment of post-stroke lower limb spasticity.


Copyright © 2010, The Japanese Association of Rehabilitation Medicine. All rights reserved.

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電子版ISSN 印刷版ISSN 1881-3526 日本リハビリテーション医学会

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