Efficacy and safety of treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity
Language English Country Sweden Media print
Document type Clinical Trial, Journal Article, Multicenter Study
PubMed
21533328
DOI
10.2340/16501977-0796
Knihovny.cz E-resources
- MeSH
- Safety MeSH
- Botulinum Toxins, Type A administration & dosage adverse effects therapeutic use MeSH
- Time Factors MeSH
- Stroke complications physiopathology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Injections, Intramuscular MeSH
- Middle Aged MeSH
- Humans MeSH
- Neuromuscular Agents administration & dosage adverse effects therapeutic use MeSH
- Arm physiopathology MeSH
- Disability Evaluation MeSH
- Prospective Studies MeSH
- Aged MeSH
- Muscle Spasticity drug therapy etiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Names of Substances
- Botulinum Toxins, Type A MeSH
- Neuromuscular Agents MeSH
OBJECTIVE: To investigate the efficacy and safety of repeated treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity. PATIENTS AND DESIGN: After completing a double-blind, placebo- controlled, multicentre study (up to 20 weeks), 145 patients received up to 5 additional sets of NT 201 injections for an open-label extension period of up to 69 weeks. METHODS: Upper limb muscle groups were treated as clinically indicated; injection intervals were ≥ 12 weeks. Outcome was assessed 4 weeks after each injection session and at the end of the study. RESULTS: Muscle tone (flexors of wrist, elbow, finger, and thumb, and forearm pronators) improved throughout the study (response rate: up to 80.6%, p < 0.0001, Ashworth Scale). Continuous and significant improvements were also observed in disability (p < 0.05, Disability Assessment Scale). The majority of investigators, patients and caregivers rated NT 201 efficacy as very good or good (56-84%). Adverse events considered treatment-related occurred in 11% of patients. Formation of neutralizing antibodies was not observed in any patient after repeated treatments. CONCLUSION: Treatment with NT 201 showed sustained improvements in muscle tone and functionality (median dose 400 units) over a study duration of up to 89 weeks, and was well tolerated during repeated treatments for post-stroke upper limb spasticity.
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
