Observational Cohort Study of Exposure to Galcanezumab during Pregnancy (I5Q-MC-B003)

Study identification

• EU PAS number:
  EUPAS27574
• Study ID:
  48767
• Official title and acronym:
  Observational Cohort Study of Exposure to Galcanezumab during Pregnancy (I5Q-MC-B003)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  No information provided.
• Study status:
  Ongoing

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned:21/01/2019

Actual:25/01/2019

Study start date

Planned:31/10/2020

Actual:30/10/2020

Date of final study report

Planned:31/12/2025

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)?:
  EU RMP category 3 (required)