Study identification

EU PAS number

EUPAS1000000408

Study ID

1000000408

Official title and acronym

Observational Cohort Study of Zavegepant Safety in Pregnancy within a US Claims Database

DARWIN EU® study

No

Study countries

United States

Study description

While no adverse developmental effects were observed in zavegepant animal studies, there are limited data on the safety of zavegepant use in pregnant individuals.
The purpose of this study is to assess the safety of zavegepant when used in pregnancy in terms of risk of major congenital malformations (MCMs), spontaneous abortions, pregnancy complications (pre-eclampsia, eclampsia, gestational diabetes, gestational hypertension), stillbirths, preterm births, and small for gestational age (SGA) births.
This non-interventional study is designated as a post-authorization safety study (PASS) and is a post-marketing commitment to the FDA.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Monica Bertoia

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable