Post-Authorization Safety Study to Assess the Effectiveness of the Newly Implemented Risk Minimization Measures for Topiramate: HCP and Patient Knowledge and Behavior Survey

Study type

• Study topic:
  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:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TOPIRAMATE
• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX11) topiramate

  topiramate
• Medical condition to be studied:
  Epilepsy

  Migraine

Population studied

• Short description of the study population:
  The target population of the survey will be composed of women of childbearing potential (WOCBP) who are treated with topiramate and HCPs grouped into three categories: 1) those who prescribe topiramate, 2) those who dispense topiramate, and 3) those who consult with or see patients receiving topiramate, in the targeted countries.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  500

Study design details

• Study design:
  Cross-sectional, multinational, non-interventional survey among HCPs involved in prescription, dispensing, and/or consultation of topiramate mono-component products and WOCBP (≥13 to ≤49 years of age) exposed to it for migraine and/or epilepsy in 6 European countries (5 EU member states and the UK)
• Main study objective:
  To assess the impact of the newly implemented RMMs on the knowledge and self-reported behavior of HCPs who prescribe topiramate mono-component products and of patients treated with topiramate mono-component products in the EU and UK.; ; To assess the awareness of:; WOCBP treated with topiramate mono-component products with respect to the receipt of the Educational Materials (EMs).; HCPs with respect to the receipt of/access to Direct Healthcare Professional Communications (DHPC) and EMs for topiramate mono-component products.; ; To assess the knowledge of:; WOCBP treated with topiramate mono-components products, with respect to risks associated with use of topiramate during pregnancy and measures to prevent exposed pregnancies.; HCPs with respect to risks associated with use of topiramate during pregnancy and measures to prevent pregnancies among WOCBP exposed to topiramate mono-component products.; ; To assess the self-reported behavior of:; WOCBP treated with topiramate mono-component products, with respect to measures to prevent exposed pregnancies.; HCPs with respect to measures to prevent pregnancies among WOCBP exposed to topiramate mono-component products.;
• Outcomes:
  The HCP and patient surveys will begin with screening questions, followed by items assessing awareness, knowledge, and behavior. For each dimension, the proportion of participants who correctly respond to at least 80% of the relevant questions will be calculated.
• Data analysis plan:
  Data from patients and HCPs will be analyzed separately, with all analyses being descriptive. The patient dataset will be analyzed by indication, while the HCP will be analyzed by (1) HCP category and (2) medical specialty. The main analysis will be conducted for all countries combined, for all EU countries (excluding the UK), and for each individual country.; Within the HCP and patient datasets, a derived variable in the form of a score summarizing all responses at individual participant level will be created for each of the main dimensions of the survey (awareness, knowledge, and behavior). The individual score will be calculated as the proportion of correct responses to all questions within each domain. Success for each dimension is defined as a score of at least 80%. ; For each dimension, the number and proportion of participants who have a score of at least 80% will be calculated. Success for each dimension is defined as having at least 80% of successful participants.; At a study level (i.e., all dimensions combined), the newly implemented RMMs will be considered satisfactory if the behavior outcome and at least one of the two other outcomes (awareness and/or knowledge) are equal to or above the defined threshold of 80% of successful participants.