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

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

Carelon

Study timelines

Date when funding contract was signed

Planned:12/02/2020

Actual:12/02/2020

Study start date

Planned:28/01/2022

Actual:07/12/2021

Date of final study report

Planned:29/12/2028

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