Effectiveness and Safety of SMART BoNT-A therapy with Dysport® in patients with post-stroke chronic upper limb spasticity in real-life setting (SMART-NIS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  SMART AbobotulinumtoxinA (AboBoNT-A; Dysport®)
• Additional medical condition(s):
  Post-stroke chronic upper limb spasticity

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  116

Study design details

• Main study objective:
  To assess the effectiveness of AboBoNT-A SMART injections as Disability Assessment Scale (DAS) score on the Principal Target of Treatment (PTT) for the upper limb.
• Outcomes:
  - Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb. ; - Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG). ; - Change from baseline of pain assessed with Visual Analogue Scale (VAS).; - Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D).; - Incidence of Adverse Events (AEs).; - Incidence of Special Situations (SS).
• Data analysis plan:
  All effectiveness analysis will be based on the Full Analysis Set population. Safety analysis will be performed on the safety population.