Efficacy and safety of botulinum neurotoxin NT 201 in poststroke upper limb spasticity
Language English Country United States Media print
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Pain chemically induced physiopathology MeSH
- Headache chemically induced physiopathology MeSH
- Botulinum Toxins, Type A adverse effects therapeutic use MeSH
- Stroke complications drug therapy physiopathology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Arm * physiopathology MeSH
- Aged MeSH
- Muscle Spasticity drug therapy etiology physiopathology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Botulinum Toxins, Type A MeSH
- incobotulinumtoxinA MeSH Browser
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.
Department of Neurology Palacky University Medical School University Hospital Olomouc Czech Republic
References provided by Crossref.org
Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults
Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity
Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders
