title: Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study.
abstract: BACKGROUND
  In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity.
  
  
  OBJECTIVE
  To assess the safety and evaluate the effects of BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle's spasms, as well as its efficacy and rate of satisfaction for patients and for the physicians.
  
  
  METHODS
  Prospective open-label study.
  
  
  METHODS
  Patients (71) with post-stroke lower limb spasticity at least 5 months by the event.
  
  
  METHODS
  Intramuscular injections of BTX-A NT 201 in soleus, medial, and lateral gastrocnemius with a maximum total dose of 180 U. Each patients was assessed at baseline, 30, and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators.
  
  
  RESULTS
  Patients treated with BTX-A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days, persisting also at 90 days of follow-up.
  
  
  CONCLUSIONS
  BTX-A NT 201 for the treatment of post-stroke lower limb spasticity was safe and efficacious reducing muscle tone and spasms, and improving passive ankle dorsi-flexion movement.
  
  
  CONCLUSIONS
  These results confirmed the safety and effectiveness of a new type of BTX-A, with low immunogenity, useful to improve rehabilitative treatment of post-stroke lower limb spasticity.
authors.affiliation: Department of Physical Medicine and Rehabilitation OORR Hospital, University of Foggia, Foggia, Italy - a.santamato@unifg.it.
authors.forename: A
authors.initials: A
authors.lastname: Santamato
authors.forename: M F
authors.initials: MF
authors.lastname: Micello
authors.forename: F
authors.initials: F
authors.lastname: Panza
authors.forename: F
authors.initials: F
authors.lastname: Fortunato
authors.forename: A
authors.initials: A
authors.lastname: Pilotto
authors.forename: A
authors.initials: A
authors.lastname: Giustini
authors.forename: A
authors.initials: A
authors.lastname: Testa
authors.forename: P
authors.initials: P
authors.lastname: Fiore
authors.forename: M
authors.initials: M
authors.lastname: Ranieri
authors.forename: R
authors.initials: R
authors.lastname: Spidalieri
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007558:Italy; D035002:Lower Extremity; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D018482:Muscle, Skeletal / Q000187:drug effects; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D020127:Recovery of Function / Q000187:drug effects; D020521:Stroke / Q000150:complications*
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA