Status: Planned First registered on: 14/02/2019
Last updated on: 01/04/2020
1. Study identification
EU PAS Register NumberEUPAS28151
Official titleProspective pregnancy study to assess maternal and fetal outcomes following exposure to galcanezumab
Study title acronymI5Q-MC-B005
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameSyneos
Centre locationWilmington, NC, USA
Details of (Primary) lead investigator
Title Dr
Last name Schroeder
First name Krista
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/02/201919/02/2019
Start date of data collection30/04/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/2033
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly & Co.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schroeder
First name Krista
Address line 1Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)1-3172763039 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Schroeder 
First name Krista 
Address line 1Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)1-3172763039 
Alternative phone number 
Fax number (incl. country code) 
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