A prospective, registry based, observational study to asses maternal, fetal and infant outcomes following exposure to lasmiditan

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46192
• EU PAS number:
  EUPAS44973
• Study ID:
  46192
• Official title and acronym:
  A prospective, registry based, observational study to asses maternal, fetal and infant outcomes following exposure to lasmiditan
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of the study is to prospectively evaluate pregnancy/fetal, maternal and infant outcomes through 12 months of age among women exposed to lasmiditan during pregnancy, as well as in a comparator group not exposed to lasmiditan.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 14/02/2020

Actual: 14/02/2020

Study start date

Planned: 31/01/2022

Actual: 01/12/2021

Date of final study report

Planned: 29/12/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

Non-interventional PASS Protocol_B001_v1.0_15Sep2021_CLEAN_Jan22_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable