An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union – 2019

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35868
• EU PAS number:
  EUPAS35867
• Study ID:
  35868
• Official title and acronym:
  An Evaluation of the Misuse and Abuse of Pregabalin using RADARS® System Programs in the United States and the European Union – 2019
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  United States
• Study description:
  The primary objectives of this evaluation:1) Summarize misuse and abuse data for pregabalin and each comparator within each country for each data source2) Summarize patterns of polysubstance use of drugs for pregabalin and each comparator to assess frequency of joint use of drugs within each country, data source, and time period of interest
• Study status:
  Planned

Research institutions and networks

Institutions

RADARS® System

Rocky Mountain Poison & Drug Safety,Denver Health and Hospital Authority

Study timelines

Date when funding contract was signed

Planned: 24/10/2019

Study start date

Planned: 15/03/2021

Data analysis start date

Planned: 30/03/2020

Date of final study report

Planned: 31/08/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A0081366 Pregabalin Study Protocol V1 08JUNE2020

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

A0081366