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

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

Study timelines

Date when funding contract was signed

Planned: 25/05/2023

Actual: 25/05/2023

Study start date

Planned: 01/01/2025

Actual: 01/01/2025

Data analysis start date

Planned: 02/01/2031

Date of interim report, if expected

Planned: 30/06/2025

Date of final study report

Planned: 30/06/2032

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

Other study registration identification numbers and links

C5301027