A Post Marketing Safety Study of Lasmiditan (REYVOW®) to describe the use in pregnant women and pregnancy outcomes using the Japan Medical Data Center Database (H8H-MC-B011)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106767
• EU PAS number:
  EUPAS106766
• Study ID:
  106767
• Official title and acronym:
  A Post Marketing Safety Study of Lasmiditan (REYVOW®) to describe the use in pregnant women and pregnancy outcomes using the Japan Medical Data Center Database (H8H-MC-B011)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  To describe lasmiditan use during pregnancy and to estimate the prevalence of pregnancy adverse events (spontaneous abortions, stillbirths, major congenital malformations, low birth weight, and preterm births) in pregnant women with migraine who are exposed to lasmiditan.
• Study status:
  Planned

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 19/09/2023

Study start date

Planned: 01/06/2022

Date of final study report

Planned: 30/09/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly Japan K.K.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only