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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/49298
• EU PAS number:
  EUPAS14611
• Study ID:
  49298
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A drug utilisation study, conducted in the Clinical Practice Research Datalink (CPRD) in the paediatric population from 6 to 17 years of age to evaluate whether recommendations in the SmPC regarding dosing and risk mitigation strategies are being adhered to by general practitioners.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Study timelines

Date when funding contract was signed

Actual: 31/05/2016

Study start date

Planned: 15/08/2016

Actual: 15/08/2016

Date of final study report

Planned: 30/12/2016

Actual: 08/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)