• Hitoshi Kagaya, Yoshihisa Masakado, Eiichi Saitoh, Toshiyuki Fujiwara, Masahiro Abo, Izumi Shin-Ichi SI Tohoku University Hospital, Miyagi, Japan., Hiroyuki Nodera, Andrzej Dekundy, Reinhard Hiersemenzel, Christiane Martina Nalaskowski, Angelika Hanschmann, and Ryuji Kaji.
• Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.
• Curr Med Res Opin. 2020 May 1; 36 (5): 827-834.

AbstractIntroduction: The safety and tolerability of incobotulinumtoxinA 400 U for upper- and lower-limb post-stroke spasticity was assessed in a small cohort of Japanese patients during the open-label lead-in tolerability periods (LITP) of two phase 3 studies (CTI-153029 and CTI-153030; Japan Pharmaceutical Information Centre).Methods: Adult patients received a single incobotulinumtoxinA injection session (total dose of 400 U) in the upper (J-PURE) or lower limb (J-PLUS). Adverse events (AEs) were assessed at 1, 4, 8 and 12 weeks post-injection during the 12 week follow-up.Results: The LITP of J-PURE and J-PLUS included 11 patients each. Mild/moderate AEs were reported by 5/11 (45.5%) and 8/11 (72.7%) patients in J-PURE and J-PLUS, respectively. No serious AEs were reported. Non-serious, transient AEs of special interest reported by two patients in J-PURE comprised muscular weakness and eyelid ptosis. No patient discontinued due to AEs.Conclusion: Preliminary results in this small population suggest that incobotulinumtoxinA 400 U is well tolerated for treating upper- or lower-limb post-stroke spasticity in Japanese patients.

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