ABSTRACT
Objective : To evaluate the efficacy and safety of botulinum toxin type A (BTXA) in Japanese patients with post-stroke lower 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 twenty patients with lower limb spasticity were randomized to receive a single treatment with BTXA 300 Units (U) or placebo into lower limb muscles in the double-blind phase. Patients who met the re-injection criteria received up to 3 repeated treatments of BTXA into lower 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 in the Modified Ashworth Scale (MAS) ankle score between the BTXA 300U and placebo groups, with a mean difference in the area under the curve (AUC) of -3.428 (<i>p</i>=0.006, t test). The MAS ankle 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 reduced spasticity in lower limb muscles from the first treatment with continued long-term efficacy. BTXA is safe and effective for the long-term treatment of post-stroke lower limb spasticity.