Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000335

EU PAS number

EUPAS1000000335

Study ID

1000000335

Official title and acronym

Prospective, Registry-Based Observational Cohort Study of Zavegepant Safety in Pregnancy

DARWIN EU® study

No

Study countries

United States

Study description

In March 2023, the US FDA approved zavegepant (ZAVZPRET) for the acute treatment of migraine with or without aura in adults. Zavegepant is the first CGRP receptor antagonist available to patients in nasal spray form. CGRP receptor antagonists represent the newest class of migraine treatments that reduce pain through interfering with CGRP-induced vasodilation and inflammation.

Migraine is common, especially among women, with a prevalence of 21% in US women and 10% in US men. Prevalence peaks in mid-life and women of reproductive age carry the greatest migraine burden. Migraine is associated with a higher risk of some adverse pregnancy outcomes including pre-eclampsia and gestational
hypertension.

While no adverse developmental effects were observed in zavegepant animal studies, there are limited data on the safety of zavegepant use in pregnant individuals (ZAVZPRET label 2023). This study will address this gap in information on the safety of zavegepant when used in pregnancy in terms of risk of maternal and/or infant outcomes. This will be a new, product-based registry that recruits pregnant women with migraine as well as pregnant women taking zavegepant. This non-interventional study (NIS) is designated as a postauthorization safety study (PASS) and is a post-marketing commitment to the FDA.

Study status

Planned
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:

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%
Study protocol
Initial protocol

C5301026_ZAVEGEPANT PREGNANCY REGISTRY PROTOCOL_V3.0_06SEP2024.pdf

English (982.13 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable