Study identification

PURI

https://redirect.ema.europa.eu/resource/45953

EU PAS number

EUPAS45952

Study ID

45953

Official title and acronym

Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

DARWIN EU® study

No

Study countries

United States

Study description

The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups, one of pregnant women with migraine treated with other medications indicated for the acute treatment or prevention of migraine during pregnancy, and a group of pregnant women without migraine. This is an observational, retrospective, cohort study using prospectively collected secondary health care data from a single US data source.

Study status

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Optum
Germany
First published:
07/02/2014
Institution
OtherENCePP partner
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Monica Bertoia

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of interim report, if expected

Planned:
Actual:

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

C4951006_PROTOCOL_V1.0_08DEC2021.pdf

English (1.63 MB - PDF)View document
Updated protocol

C4951006_PROTOCOL_V5.0_21AUG2023.pdf

English (1.6 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only