Abstract

Objective: To evaluate the safety of botulinum toxin type B (BXT-B) in the treatment of lower-limb adductor spasticity in subjects with multiple sclerosis (MS). Design: Double-blind, placebo-controlled, single-treatment, sequential dose escalation safety study. Setting: Outpatient clinics. Participants: Subjects had clinically definite MS with bilateral lower-limb adductor spasticity (duration, >6mo). Intervention: Subjects were randomized in a 5 to 1 ratio to receive BXT-B (1 of 5 successive doses [25,000U, 30,000U, 35,000U, 40,000U, 45,000U]) or placebo.

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