Vyepti Pregnancy Registry: A prospective, comparative cohort study of maternal, fetal and infant safety in pregnant women exposed to eptinezumab in the United States

Study identification

• EU PAS number:
  EUPAS1000000936
• Study ID:
  1000000936
• Official title and acronym:
  Vyepti Pregnancy Registry: A prospective, comparative cohort study of maternal, fetal and infant safety in pregnant women exposed to eptinezumab in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  National, prospective cohort study in pregnant women with migraine exposed to eptinezumab or non-CGRP targeting preventive migraine medications, during pregnancy or up to 5 drug half-lives prior to the estimated conception date. Patients will be included in an US national pregnancy registry and followed-up until end of pregnancy. In case of a live birth, additional follow-up for 12 months will be conducted to collect information on infant health and development.
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

H. Lundbeck

Study timelines

Date when funding contract was signed

Planned:31/07/2022

Actual:03/08/2022

Study start date

Planned:30/05/2024

Actual:30/09/2024

Date of interim report, if expected

Planned:31/12/2023

Actual:05/12/2023

Date of final study report

Planned:31/12/2036

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)