Last updated on June 2018

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity


Brief description of study

Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400 units of botulinum toxin A which can help to increase the maximum dose per administration to 400 units from 240 units as the treatment with 240 units is considered insufficient in subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase followed by open-label phase in which 400 units of the study treatment will be injected in both the groups. The study period will be up to 52 weeks, consisting of a screening phase up to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).

Clinical Study Identifier: NCT03261167

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Aichi, Japan

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Fukuoka, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyogo, Japan

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Ibaraki, Japan

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Kanagawa, Japan

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Kumamoto, Japan

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Nagano, Japan

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Okayama, Japan

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Osaka, Japan

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Saga, Japan

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Shizuoka, Japan

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Tokyo, Japan

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Yamagata, Japan

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Chiba, Japan

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Fukui, Japan

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Kagoshima, Japan

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Kochi, Japan

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Niigata, Japan

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Oita, Japan

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Tokushima, Japan

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Wakayama, Japan