A post marketing surveillance survey of Dysport for evaluating safety of Dysport in Korean patients suffering from Spasticity or Dystonia

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open, non-randomised, multi-centre, non-interventional, post-marketing survey

Study drug and medical condition

• Name of medicine, other:
  Dysport (UK)
• Anatomical Therapeutic Chemical (ATC) code:
  (M03AX01) botulinum toxin

  botulinum toxin
• Medical condition to be studied:
  Cerebral palsy
• Additional medical condition(s):
  Equinus SpasticityCervical DystoniaHemifacial spasmSpasticity

Population studied

• Short description of the study population:
  Each Investigator will maintain a record of all subjects enrolled into the survey.; It is planned to recruit approximately 500 subjects in approximately 20 centres in Korea.; All subjects must fulfil the following:; 1) Subjects with indication disease scheduled to receive Dysport as per normal treatment practice, and in respect with Dysport SmPC.; 2) Adult or child over the age of 2 years; Subjects will not be included in the survey if :; 1) Subject has hypersensitivity to Dysport or drugs with a similar chemical structure.; 2) Treatment with any other investigational drug within the last 30 days before survey entry.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  481

Study design details

• Main study objective:
  To provide a further assessment of the benefit/risk effect of Dysport as a marketed product in Korean subjects suffering from spasticity or dystonia.
• Outcomes:
  Safety endpoint was the AEs, more specifically the number of AEs and the percentage of subjects with any AE.
• Data analysis plan:
  The sample size of 500 is based on feasibility and not on any statistical considerations. In terms of study reporting, the analysis is descriptive: data summaries consist of descriptive statistics like counts, means, standard deviations, medians, minima, maxima or frequencies / percentages as appropriate. The safety analysis is based on the safety population (defined as all treated patients).

Documents

Study results

a3852120114-synopsis