Pregnancy, fetal and infant outcomes of pregnancies exposed to eptinezumab compared to two migraine control cohorts unexposed to eptinezumab: a claims database study in the United States

Study identification

• EU PAS number:
  EUPAS1000000938
• Study ID:
  1000000938
• Official title and acronym:
  Pregnancy, fetal and infant outcomes of pregnancies exposed to eptinezumab compared to two migraine control cohorts unexposed to eptinezumab: a claims database study in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective cohort study of pregnant women with a diagnosis of migraine and treated with eptinezumab compared to two control cohorts: (1) Women with migraine who have been exposed to preventive migraine medications other than eptinezumab and other CGRP monoclonal antibodies before or during pregnancy (primary control cohort); (2) women with migraine who have not been exposed to eptinezumab or any preventive migraine medication (secondary control cohort)
• Study status:
  Ongoing

Research institutions and networks

Institutions

H. Lundbeck

Merative US L.P.

Study timelines

Date when funding contract was signed

Planned:03/03/2023

Actual:03/03/2023

Study start date

Planned:15/11/2023

Actual:15/11/2023

Data analysis start date

Planned:15/11/2023

Actual:15/11/2023

Date of interim report, if expected

Planned:31/12/2023

Actual:05/12/2023

Date of final study report

Planned:31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Lundbeck A/S

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)