Efficacy and Safety of Botulinum Type A Toxin in Adductor Spasticity Due to Multiple Sclerosis
2008
Objective: To assess the efficacy of Clostridium botulinum type A toxin-hemagglutinin complex [BoNT-A, Dysport®] in the treatment of adults with adductor muscle spasticity due to definite or probable multiple sclerosis [MS].Methods: In this 12-week multinational, randomized, double-blind, placebo-controlled trial, patients received a single treatment of either BoNT-A 1,000–1,500 Ipsen units or placebo injected into the adductor muscles of each leg [500–750 Ipsen units per leg]. The primary outcome measure was a novel, patient-selected, functional outcome measure at week 4.Results: Fifty-five subjects were treated with BoNT-A, and 51 received the placebo. Treatment benefit in favor of BoNT-A, which tended toward significance, was seen for most endpoints but not the subjective patient-selected key outcome measure. As with a previous dose-ranging study of BoNT-A, pain was significantly reduced in both legs [P < 0.05 at weeks 8 and 12]. Lack of significance for the other endpoints was probably due to the low ...
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