Objective: To confirm the efficacy and safety of incobotulinumtoxinA (INCO; Xeomin®, Merz Pharmaceuticals GmbH) in East Asian subjects from study sites in Japan with post-stroke spasticity in the lower limb (LL), using the Modified Ashworth Scale (MAS) spasticity score for the plantar flexors.
Background: Three international consensus groups have recommended botulinum toxin type A (BoNT-A) treatment for adult LL spasticity. INCO is a purified BoNT-A formulation, free from complexing proteins, with proven efficacy and tolerability in focal dystonia, chronic sialorrhea and spasticity of the upper limb.
Method: This phase III, prospective, double-blind, placebo-controlled, randomized, multi-center study (CTI-153030) started with an open-label lead-in tolerability period (LITP) comprised of one injection cycle. Eleven subjects were enrolled in LITP and received one injection of 400 U INCO. At the end of LITP, a decision was made based on a safety assessment by an Independent Data Monitoring Committee to continue in the Main Period (MP) with 400 U. A total of 208 subjects were enrolled in MP and randomized to receive one injection of INCO (n=104), or placebo (n=104) into LL muscles. Changes in MAS plantar flexor score in both groups from baseline to week 1, 4, 6, 8, and 12 were assessed and compared.
Results: The investigators assessed the tolerability of INCO as either “good” or “very good” for all subjects in LITP. The efficacy of INCO (400 U) vs placebo in subjects with post-stroke LL spasticity was confirmed by means of area under the curve (AUC) of the changes in plantar flexor MAS spasticity score throughout the MP. INCO subjects’ AUC of mean changes from baseline in the MAS plantar flexor score was statistically significant compared to placebo [LS-mean: -8.40 and -5.81; respectively (p=0.0041)]. The largest effect was seen at week 6. No safety concerns were observed with INCO treatment.
Conclusion: This study confirmed the efficacy of INCO in an East Asian population with LL spasticity, and showed that INCO at the dose of 400 U had a favorable safety and tolerability profile in this population.
To cite this abstract in AMA style:
Y. Masakado, A. Dekundy, A. Hanschmann, R. Kaji. Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-in-the-treatment-of-lower-limb-spasticity-in-japanese-subjects/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2020
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-in-the-treatment-of-lower-limb-spasticity-in-japanese-subjects/