Observational cohort study of exposure to lasmiditan during pregnancy (H8H-MC-B002)

05/01/2022
16/10/2025
EU PAS number:
EUPAS44982
Study
Ongoing
Study summary
No information provided.
Study identification

EU PAS number

EUPAS44982

Study ID

46189

Official title and acronym

Observational cohort study of exposure to lasmiditan during pregnancy (H8H-MC-B002)

DARWIN EU® study

No

Study countries

United States

Study description

This is a claims-based retrospective cohort study comparing pregnant women exposed to lasmiditan to three unexposed comparator populations.

Study status

Ongoing
Research institutions and networks

Institutions

HealthCore
First published:
01/02/2024
Institution
Carelon

Contact details

Ana Sofia Afonso

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable