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 institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner

Contact details

Joan Forns

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Study protocol
Initial protocol

C4951017_bhv3000-408 protocol v2_17 Nov 2022

English (1.29 MB - PDF)View document
Updated protocol

C4951017_PROTOCOL- RIMEGEPANT CV PASS_V3.0_26AUG2024.pdf

English (2.29 MB - PDF)View document
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)