Status: Finalised First registered on: 11/12/2020
Last updated on: 23/03/2023
1. Study identification
EU PAS Register NumberEUPAS38620
Official titleA Population-based Study of the Safety of Gabapentin Use During Pregnancy
Study title acronymNone
Study typeObservational study
Brief description of the studyThis non-interventional study is being conducted to characterize the use and safety of gabapentin during pregnancy
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableA9451182
2. Research centres and Investigator details
Coordinating study entity
Centre namePfizer
Centre locationUnited States
Details of (Primary) lead investigator
Title Dr
Last name Kofi
First name Asomaning
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Aarhus University Dept. of Clinical Epidemiology
Countries in which this study is being conducted
International study

Denmark
Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/12/202021/12/2020
Start date of data collection30/12/202030/12/2020
Start date of data analysis30/04/202130/04/2021
Date of interim report, if expected
Date of final study report31/03/202208/09/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Kofi
First name Asomaning
Address line 1500 Arcola road
Address line 2 
Address line 3 
CityCollegeville 
PostcodePA 19426 
CountryUnited States
Phone number (incl. country code)14848655557 
Alternative phone number 
Fax number (incl. country code) 
Email address kofi.asomaning@pfizer.com
Public Enquiries
Title Dr 
Last name Kofi 
First name Asomaning 
Address line 1500 Arcola road 
Address line 2 
Address line 3 
CityCollegeville 
PostcodePA 19426 
CountryUnited States 
Phone number (incl. country code)14848655557 
Alternative phone number 
Fax number (incl. country code) 
Email address kofi.asomaning@pfizer.com 
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