An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study To Monitor The Safety And Utilization Of Asenapine (Sycrest) In The Primary Care Setting In England

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23506
• EU PAS number:
  EUPAS3603
• Study ID:
  23506
• Official title and acronym:
  An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study To Monitor The Safety And Utilization Of Asenapine (Sycrest) In The Primary Care Setting In England
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Asenapine is a novel atypical antipsychotic agent, developed for the treatment of moderate to severe manic episodes associated with bipolar I disorder and schizophrenia in adults. This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) aims to systematically collect and report drug utilisation and safety data on patients newly initiated on treatment with asenapine in the primary care setting in England. The study aims to collect exposure and outcome data for a cohort of approximately 5000 evaluable patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 16/08/2011

Actual: 16/08/2011

Study start date

Planned: 01/01/2012

Actual: 01/01/2012

Data analysis start date

Planned: 01/01/2013

Actual: 01/04/2013

Date of final study report

Planned: 28/02/2018

Actual: 12/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Inc

Study protocol

Initial protocol

Asenapine MPEM protocol_FINAL_August2014

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)