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 identification

• EU PAS number:
  EUPAS1000000806
• Study ID:
  1000000806
• Official title and acronym:
  Post-Authorization Safety Study to Assess the Effectiveness of the Newly Implemented Risk Minimization Measures for Topiramate: HCP and Patient Knowledge and Behavior Survey
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  Cross-sectional, multinational, and non-interventional on-line survey to assess the impact of the newly implemented Risk Minimization Measures (RMMs) on the knowledge and self-reported behaviour of HCPs involved in prescription, dispensing, and/or consultation of topiramate mono-component products and of Women of Childbearing Potential (WOCBP) treated with topiramate mono-component products for migraine and/or epilepsy in the EU and UK.
• Study status:
  Planned

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Planned:20/09/2024

Actual:20/09/2024

Study start date

Planned:18/03/2026

Data analysis start date

Planned:17/09/2026

Date of final study report

Planned:09/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Topiramate Safety Consortium of MAHs, led by Janssen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/A-31/1520

Other study registration identification numbers and links

PCSESPA0008