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

06/11/2025
06/11/2025
EU PAS number:
EUPAS1000000806
Study
Planned

ENCePP Code of conduct

Yes
Data sources

Data source(s), other

The data source will be on-line questionnaires completed by HCPs and patients (or parents/caregivers) who have passed the screening and who have given consent.

Data sources (types)

Other
Patient surveys

Data sources (types), other

Surveys from HCPs including general practitioners (GPs), specialists in internal medicine, other specialists managing epilepsy and/or migraine (including neurologists, general pediatricians, neuro-pediatricians), obstetricians/gynecologists (OB/GYN), midwives, and pharmacists
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

Unknown