Study identification

PURI

https://redirect.ema.europa.eu/resource/39424

EU PAS number

EUPAS37499

Study ID

39424

Official title and acronym

Observational Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Erenumab-aooe During Pregnancy (20180172)

DARWIN EU® study

No

Study countries

United States

Study description

This study is being conducted to understand the safety of administering erenumab-aooe during pregnancy. Data will be collected from two large US administrative claims databases to allow for longitudinal follow-up of patient outcomes. Data from pregnant women with migraines aged 16 to 44 and their infants will be included in this study. The planned study period is approximately 9.5 years, from May 2018 to November 2027. This study will provide an assessment of erenumab-aooe utilization patterns versus other preventive and acute medications being used by pregnant women suffering from migraines. This study aims to assess the safety of erenumab-aooe on maternal, fetal, and infant outcomes resulting from the use of erenumab-aooe during pregnancy.

Study status

Ongoing
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

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

Amgen Inc.
Study protocol
Initial protocol

Protocol-Published Original erenumab 20180172 .pdf

English (5.92 MB - 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