title: 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.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurology, Palacky University Medical School University Hospital, IP Pavlova 6, CZ-775 20 Olomouc, Czech Republic. petr.kanovsky@fnol.cz
authors.forename: Petr
authors.initials: P
authors.lastname: Kaňovský
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Slawek
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Denes
authors.forename: Thomas
authors.initials: T
authors.lastname: Platz
authors.forename: Georg
authors.initials: G
authors.lastname: Comes
authors.forename: Susanne
authors.initials: S
authors.lastname: Grafe
authors.forename: Irena
authors.initials: I
authors.lastname: Pulte
mesh_terms: D000328:Adult; D000368:Aged; D001132:Arm / Q000503:physiopathology; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012449:Safety; D020521:Stroke / Q000150:complications* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A