Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity

Phase 2, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of two doses of MYOBLOC (15,000 Units and 20,000 Units)versus volume-matched placebo in the treatment of lower limb spasticity in adults. An interim analysis will evaluate all available safety and efficacy data from the Phase 2 double-blind trial in order to recommend which dose will be evaluated in subsequent Phase 3 trial. The Phase 3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of MYOBLOC versus placebo in the treatment of lower limb spasticity in adults. Subjects who complete either the Phase 2 or Phase 3 trial will continue into an open-label extension part of the study where each will receive 4 separate treatments of MYOBLOC (20,000-25,000 Units) \~13 weeks apart for lower limb spasticity.