Describing Real-World Rimegepant Utilization Patterns and Understanding Perceptions of Migraine Treatment Optimization from the Perspectives of Patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000232
• EU PAS number:
  EUPAS1000000232
• Study ID:
  1000000232
• Official title and acronym:
  Describing Real-World Rimegepant Utilization Patterns and Understanding Perceptions of Migraine Treatment Optimization from the Perspectives of Patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a cross-sectional, observational study that will collect real-world data from surveys completed by participants who reside in the United States with a migraine diagnosis currently being treated with rimegepant. There will be two phases of the study. The first phase will include survey development and cognitive pre-test interviews, and the second phase will include administering the survey and performing analysis and reporting. A closed survey composed of multiple questions will be administered to adults with migraine who reported the use of rimegepant in the three (3) months preceding survey administration. A screener questionnaire will be administrated to confirm patient's eligibility. After patient's consent, the participant will be directed to a multiple-choice dynamic survey. Key measures to be collected for the survey include migraine-specific quality of life (QoL), as well as experience, behaviors, and treatments related to migraine. Additionally, patient characteristics will be captured, including general demographic and health information. Participants will be contacted by email and will receive a link to the questionnaires. The initial invitation will be followed by one reminder to enhance participation. The data collection period is expected to last approximately nine (9) weeks.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 16/10/2023

Actual: 16/10/2023

Study start date

Planned: 05/07/2024

Actual: 12/08/2024

Data analysis start date

Planned: 07/11/2024

Actual: 06/01/2025

Date of final study report

Planned: 11/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.

Study protocol

Initial protocol

C4951068 Non Interventional Study Patient Preference Protocol V1 0 17Jun2024 Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable