Efficacy and Safety of Botulinum Toxin Type A in treating Upper Limb Spasticity in Post-stroke Patients : A Multicenter, Double-blind, Placebo-controlled Trial followed by an Open-label Trial

Abstract

Objective : To evaluate the efficacy and safety of botulinum toxin type A BTXA in Japanese patients with post-stroke upper 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 nine patients with upper limb spasticity were randomized to receive a single treatment with either a lower dose 120.150 Units ; U , higher dose 200.240 U BTXA or placebo into upper limb muscles in the double-blind phase. These treatments were administered to improve wrist and finger flexion for all patients and thumb flexion in patients with thumb spasticity. Patients who met the re-injection criteria received up to 3 repeated treatments of BTXA 200.240 U into their upper 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 on the Modified Ashworth Scale MAS wrist score between the higher dose BTXA and placebo groups, with a mean difference in the area under the curve AUC of 6.830 p0.001, t test. The MAS wrist 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 injections reduced spasticity in the upper limb muscles from the first treatment with continued long-term efficacy. Our results suggest that BTXA injections are safe and effective for the long-term treatment of post-stroke upper limb spasticity. Jpn J Rehabil Med .