E2090-E044-501: A Retrospective database Study of the Prescribing of Zonismaide in UK General Practice: A Drug Utilisation Study as Part of Post-Marketing Safety Surveillance

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective database study

Study drug and medical condition

• Name of medicine:
  ZONEGRAN
• Medical condition to be studied:
  Epilepsy

Population studied

• Short description of the study population:
  The study participants included children and adolescents aged 6-18 years who had at least one prescription for zonisamide from 2013 to 2016, using the Clinical Practice Research Datalink GOLD database.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Epilepsy patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To provide information as to whether recommendations in the product information are being adhered to with regard to the paediatric population and in order to provide evidence of the effectiveness of the routine risk minimisation measures through a retrospective database study
• Data analysis plan:
  This study will utilise descriptive methods to summarise the key outcomes used to evaluate clinical care and prescribing for children taking Zonisamide. Descriptive summaries will be provided for all paediatric patients who have at least one prescription of Zonisamide, and then further stratified into groups A, B and C, depending on the presence of an epilepsy diagnosis within the patient’s medical record. No comparisons will be made between such groups, nor will any formal comparison testing be undertaken. Additionally as this is a descriptive drug utilisation study, no testing of statistical hypotheses, statistical modelling or other multivariate analyses will be performed.

Documents

Study results

e2090-e044-501-abstract-redact - PAs register