Effectiveness of the Mysimba Physician Prescribing Checklist (PPC): Focus group to assess understanding, attitude, and behaviour for usage of the PPC and for key safety messages (NB-453 PPC focus groups)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103749
• EU PAS number:
  EUPAS103748
• Study ID:
  103749
• Official title and acronym:
  Effectiveness of the Mysimba Physician Prescribing Checklist (PPC): Focus group to assess understanding, attitude, and behaviour for usage of the PPC and for key safety messages (NB-453 PPC focus groups)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Greece

  Norway
• Study description:
  This is a follow-up study to the NB-452 Physician Prescribing Checklist (PPC) survey study in which 71.3% (95%CI 64.9%, 77.1%) of Mysimba prescribers met the overall knowledge and understanding (KAU) criteria (primary outcome), which did not reach the pre-specified threshold of 85% for effectiveness of the PPC. Prior to developing a strategy for improving the awareness, usage and understanding of the Mysimba PPC, or making any modification to the risk minimisation strategy, it is necessary to conduct a root cause analysis of low awareness of the PPC as well as of incorrect responses to survey questions related to knowledge and understanding of selected key safety messages. This focus group study will be conducted to help determine the adequacy of the Mysimba PPC, and potentially guide strategies to improve the understanding of key safety messages described in the EU RMP for Mysimba.
• Study status:
  Finalised

Research institutions and networks

Institutions

Currax Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 14/12/2022

Actual: 14/12/2022

Study start date

Planned: 31/03/2023

Actual: 31/03/2023

Data analysis start date

Planned: 30/06/2023

Actual: 30/06/2023

Date of final study report

Planned: 30/09/2023

Actual: 23/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orexigen Therapeutics/Currax Pharmaceuticals LLC

Study protocol

Initial protocol

NB-453 Focus Group Protocol_05 DEC 2022_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)

Other study registration identification numbers and links

NB-453, EMEA/H/C/003687/II/0054