A Population-based Study of the Safety of Gabapentin Use During Pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49994
• EU PAS number:
  EUPAS38620
• Study ID:
  49994
• Official title and acronym:
  A Population-based Study of the Safety of Gabapentin Use During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  This non-interventional study is being conducted to characterize the use and safety of gabapentin during pregnancy
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Multiple centres: 4 centres are involved in the study

Contact details

Asomaning Kofi

Study contact

[e-mail]

Asomaning Kofi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 21/12/2020

Actual: 21/12/2020

Data collection

Planned: 30/12/2020

Actual: 30/12/2020

Start date of data analysis

Planned: 30/04/2021

Actual: 30/04/2021

Date of final study report

Planned: 31/03/2022

Actual: 08/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

A9451182_Gabapentin_FINAL STUDY PROTOCOL_V1_02 October 2020

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)

Other study registration identification numbers and links

A9451182