WEUKBRE5744: European Survey of Patient and Prescriber Understanding of Risks Associated with TROBALT™ (116771)

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:
  Cross-sectional

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Neurologists prescribing AEDs and who have been sent the TROBALT Physician's guide.; ; Inclusion criteria:; 1. Must have prescribed an AED at least once in the last 3 months; 2. Must be on the list to which the Physician's Guide for TROBALT was distributed; ; Exclusion:; 1. Currently an employee of GSK or UBC
• 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:
  350

Study design details

• Main study objective:
  The objectives of this study are to assess patients’ and prescribers’ understanding and knowledge of the significant risks associated with TROBALT use as evaluated by a survey instrument.
• Outcomes:
  The primary outcome of the survey is the proprtion of patients/neurologists providing correct responses to a series of questions concerning the significant risks associated with TROBALT. The risks evaluated will be those described in the TROBALT PIL and in the Physician's Guide.
• Data analysis plan:
  The population for analysis will comprise all neurologists recruited into the study, meeting eligibility criteria as assessed in the survey screener, and completing the survey.The outcomes (proportion of respondents answering each question correctly) will be summarised for all countries combined, and then for all countries combined not including Germany, with a separate analysis for Germany. The sub-population for analyses will be the neurologists who have ever prescribed TROBALT.For patients, the population for analysis will be all patients included in the study who completed the survey. Patient demographics and indication for TROBALT use will be summarized. The primary outcome is the proportion of patients answering each question correctly. The countries will be combined, with and without Germany. The sub-population for analyses will be by demographic characteristics such as country.

Documents

Study results

116771-clinical-study-report-redact