NB-452: A cross-sectional survey to evaluate the effectiveness of the Mysimba® Physician Prescribing Checklist (PPC) among physicians in the European Union (EU)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42492
• EU PAS number:
  EUPAS42491
• Study ID:
  42492
• Official title and acronym:
  NB-452: A cross-sectional survey to evaluate the effectiveness of the Mysimba® Physician Prescribing Checklist (PPC) among physicians in the European Union (EU)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Greece

  Hungary

  Norway

  Poland
• Study description:
  The study is to assess the effectiveness of the PPC through evaluation of physician awareness and utilisation of the PPC, knowledge of the contraindications, warnings, precautions of Mysimba, knowledge of factors that may increase the risk of adverse reactions, and impact upon a physician’s behaviour with respect to mitigating the risks in patients receiving Mysimba therapy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ergomed

Study timelines

Date when funding contract was signed

Actual: 10/08/2020

Study start date

Actual: 25/03/2021

Date of final study report

Planned: 29/10/2021

Actual: 24/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Currax Pharmaceuticals LLC

Study protocol

Initial protocol

NB-452 Protocol_FINAL

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)