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Botulinum toxin type A in post-stroke upper limb spasticity.
Curr Med Res Opin. 2010 Aug; 26(8):1983-92.CM

Abstract

OBJECTIVE

To evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity.

RESEARCH DESIGN AND METHODS

In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 patients with upper limb spasticity were randomised to receive a single treatment with lower-dose (120-150 U) or higher-dose (200-240 U) BoNTA or placebo into upper limb muscles.

CLINICAL TRIAL REGISTRATION

NCT00460564.

MAIN OUTCOME MEASURES

The tone of the wrist flexor was assessed at baseline and at weeks 0, 1, 4, 6, 8 and 12 using the Modified Ashworth Scale (MAS) for wrist, finger, thumb and disability in activities of daily living (ADL) was rated using the 4-point Disability Assessment Scale (DAS). The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS wrist score in the higher-dose groups.

RESULTS

Subjects were randomised with 51 in the higher BoNTA group, 26 in the higher-dose placebo group, 21 in the lower BoNTA group and 11 in the lower-dose placebo group. Significant improvement in spasticity with higher-dose BoNTA was demonstrated by a mean difference in the AUC of the change from baseline in the MAS wrist score between the higher-dose BoNTA group and the higher-dose placebo group of -6.830 (p < 0.001, t-test), no significant different was demonstrated between the lower-dose BoNTA group and the lower-dose placebo group (p = 0.215, t-test). Significant improvements with higher-dose BoNTA were also observed in the DAS scores for limb position (p = 0.001-0.022) at all time points and dressing (p = 0.018-0.038, Wilcoxon test) at weeks 6, 8 and 12. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BoNTA-treated and placebo-treated patients. The long-term efficacy and safety, and the effects on rehabilitation of BoNTA on upper limb will be evaluated using the data obtained in the open-label phase.

CONCLUSIONS

Higher-dose BoNTA reduced spasticity in upper limb muscles and improved ADL performance in terms of limb position and dressing. BoNTA is safe and effective in the treatment of post-stroke upper limb spasticity.

Authors+Show Affiliations

Department of Clinical Neuroscience, Institute of Health Biosciences, Tokushima University Graduate School, Tokushima City, Tokushima, Japan. rkaji@clin.med.tokushima-u.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20569068

Citation

Kaji, Ryuji, et al. "Botulinum Toxin Type a in Post-stroke Upper Limb Spasticity." Current Medical Research and Opinion, vol. 26, no. 8, 2010, pp. 1983-92.
Kaji R, Osako Y, Suyama K, et al. Botulinum toxin type A in post-stroke upper limb spasticity. Curr Med Res Opin. 2010;26(8):1983-92.
Kaji, R., Osako, Y., Suyama, K., Maeda, T., Uechi, Y., & Iwasaki, M. (2010). Botulinum toxin type A in post-stroke upper limb spasticity. Current Medical Research and Opinion, 26(8), 1983-92. https://doi.org/10.1185/03007995.2010.497103
Kaji R, et al. Botulinum Toxin Type a in Post-stroke Upper Limb Spasticity. Curr Med Res Opin. 2010;26(8):1983-92. PubMed PMID: 20569068.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Botulinum toxin type A in post-stroke upper limb spasticity. AU - Kaji,Ryuji, AU - Osako,Yuka, AU - Suyama,Kazuaki, AU - Maeda,Toshio, AU - Uechi,Yasuyuki, AU - Iwasaki,Masaru, AU - ,, PY - 2010/6/24/entrez PY - 2010/6/24/pubmed PY - 2010/9/21/medline SP - 1983 EP - 92 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 26 IS - 8 N2 - OBJECTIVE: To evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity. RESEARCH DESIGN AND METHODS: In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 patients with upper limb spasticity were randomised to receive a single treatment with lower-dose (120-150 U) or higher-dose (200-240 U) BoNTA or placebo into upper limb muscles. CLINICAL TRIAL REGISTRATION: NCT00460564. MAIN OUTCOME MEASURES: The tone of the wrist flexor was assessed at baseline and at weeks 0, 1, 4, 6, 8 and 12 using the Modified Ashworth Scale (MAS) for wrist, finger, thumb and disability in activities of daily living (ADL) was rated using the 4-point Disability Assessment Scale (DAS). The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS wrist score in the higher-dose groups. RESULTS: Subjects were randomised with 51 in the higher BoNTA group, 26 in the higher-dose placebo group, 21 in the lower BoNTA group and 11 in the lower-dose placebo group. Significant improvement in spasticity with higher-dose BoNTA was demonstrated by a mean difference in the AUC of the change from baseline in the MAS wrist score between the higher-dose BoNTA group and the higher-dose placebo group of -6.830 (p < 0.001, t-test), no significant different was demonstrated between the lower-dose BoNTA group and the lower-dose placebo group (p = 0.215, t-test). Significant improvements with higher-dose BoNTA were also observed in the DAS scores for limb position (p = 0.001-0.022) at all time points and dressing (p = 0.018-0.038, Wilcoxon test) at weeks 6, 8 and 12. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BoNTA-treated and placebo-treated patients. The long-term efficacy and safety, and the effects on rehabilitation of BoNTA on upper limb will be evaluated using the data obtained in the open-label phase. CONCLUSIONS: Higher-dose BoNTA reduced spasticity in upper limb muscles and improved ADL performance in terms of limb position and dressing. BoNTA is safe and effective in the treatment of post-stroke upper limb spasticity. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/20569068/Botulinum_toxin_type_A_in_post_stroke_upper_limb_spasticity_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007995.2010.497103 DB - PRIME DP - Unbound Medicine ER -