Post marketing surveillance (non-interventional study) for evaluating the efficacy and safety of Dysport Czech patients suffering from post-stroke arm spasticity

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• 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 study

Study drug and medical condition

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

  botulinum toxin
• Medical condition to be studied:
  Muscle spasticity

Population studied

• Short description of the study population:
  Adult subjects with Post-Stroke Arm Spasticity newly scheduled to receive Dysport, with stroke onset at least 3 months prior to study entry, within each participating centre are to be included in this Study. All subjects should rehabilitate under professional inspection at the same time.; Study Inclusion Criteria; All subjects must fulfil the following:; 1. Subjects with stroke either haemorrhagical or ischemic origin and stroke onset at least 3 months prior to study entry scheduled to receive Dysport.; 2. Adults over the age of 18 years; 3. Arm spasticity with Modified Ashworth scale  2 at least in one part; Study Exclusion Criteria; Subjects presenting with any of the following will not be included in the Study:; 1. Hypersensitivity to any Dysport ingredient; 2. Pregnancy; 3. Previous administration of botulinum toxin
• 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:
  48

Study design details

• Main study objective:
  To provide a further assessment of the risk / benefit of Dysport as a marketed product.
• Outcomes:
  Global assessment of spasticity using the Modified Ashworth Scale, Patient´s Quality of Life (QOL) evaluation (DAS scale), Interval between separate administration sessions and monitoring of treatment related adverse events (RAEs).
• Data analysis plan:
  The statistical analysis will be only descriptive: data summaries will consist of summary statistics like counts, mean, standard deviations, medians, minima, maxima or frequencies / percentages as appropriate. ITT / safety population will be used to describe all efficacy data and safety data. e.g. risk estimation, measures of risk, internal/external validity

Documents

Study results

A-38-52120-113_synopsis_no marks