Prospective pregnancy study to assess maternal and fetal outcomes following exposure to galcanezumab (I5Q-MC-B005)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43321
• EU PAS number:
  EUPAS28151
• Study ID:
  43321
• Official title and acronym:
  Prospective pregnancy study to assess maternal and fetal outcomes following exposure to galcanezumab (I5Q-MC-B005)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 04/02/2019

Actual: 19/02/2019

Study start date

Planned: 30/04/2020

Actual: 03/05/2021

Date of final study report

Planned: 30/11/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Co.

Study protocol

Initial protocol

I5Q-MC-B005 v1_Redacted

Updated protocol

Lilly I5Q-MC-B005 v5.0_Galcanezumab_PregReg_Protocol_Amendment_CLEAN_Redacted

Regulatory

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