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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48767
• 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 status:
  Ongoing

Research institution 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: 31/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

I5Q-MC-B003 v1_Redacted

Updated protocol

I5Q-MC-B003 Protocol Amendment(c)_Redacted

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)