Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104168
• EU PAS number:
  EUPAS103990
• Study ID:
  104168
• Official title and acronym:
  Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Netherlands

  Spain

  United Kingdom
• Study description:
  As part of the risk management plan for rimegepant in Europe, this post-authorisation safety study (PASS) is being conducted to evaluate whether there is an increased risk of major adverse cardiovascular events (MACE) among patients with migraine and history of cardiovascular disease (CVD) initiating treatment with rimegepant compared with that among patients with migraine, with history of CVD, and being treated with other treatments for migraine, either continuing the current treatment or initiating a new one, other than rimegepant. The study will also describe the use of rimegepant in the initial years after approval in the same population.
• Study status:
  Planned

Research institution and networks

Institutions

Pfizer

Networks

RTI

Study timelines

Date when funding contract was signed

Planned: 01/03/2023

Actual: 01/03/2023

Study start date

Planned: 01/10/2025

Date of final study report

Planned: 01/04/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4951017_bhv3000-408 protocol v2_17 Nov 2022

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)