Efficacy and safety of botulinum neurotoxin NT 201 in poststroke upper limb spasticity.

OBJECTIVE: To assess the impact of the new botulinum neurotoxin type A preparation NT 201 (Xeomin; Merz Pharmaceuticals GmbH, Frankfurt, Germany) on muscle tone, functional disability, and caregiver burden in patients with poststroke upper limb spasticity in a randomized, placebo-controlled, double-blind study.

METHODS: One hundred forty-eight patients with an Ashworth Scale score of 2 or higher for wrist and finger flexors and at least moderate disability in their principal therapeutic target of the Disability Assessment Scale were treated either with NT 201 (median, 320 U) or placebo and followed up for up to 20 weeks. Treatment of the wrist and finger muscles was mandatory.

RESULTS: A significantly higher proportion of patients treated with NT 201 were responders (improvement of > or =1 point in the Ashworth Scale score), as observed in comparison to placebo 4 weeks after treatment in wrist flexors (odds ratio, 3.97; 95% confidence interval, 1.9-8.3; P < 0.001, intent to treat). For all treated flexor muscle groups, statistically significant odds ratios in favor of NT 201 were observed at week 4 (P < or = 0.009). Statistically significant results in favor of NT 201 were observed at all postinjection visits until week 12 in the principal therapeutic target (P < or = 0.005), in the global assessment of efficacy (P < 0.001), and in some tasks of the Carer Burden Scale (P < 0.05). Similar numbers of patients in each group experienced at least 1 adverse event (NT 201, n = 21; placebo, n = 20). Importantly, none of the patients developed neutralizing antibodies.

CONCLUSIONS: NT 201 led to statistically significant improvements in muscle tone and disability and was well tolerated in patients with poststroke upper limb spasticity.