Study identification

PURI

https://redirect.ema.europa.eu/resource/43386

EU PAS number

EUPAS43385

Study ID

43386

Official title and acronym

Methods for controlling by indication for prescriptions: application to medications for neuropathic pain

DARWIN EU® study

No

Study countries

Finland
France
Germany
Italy
Norway
United Kingdom

Study description

A large number of different medication groups are used in the treatment of neuropathic pain including gabapentinoids. Besides neuropathic pain, these medications cover a wide range of indications from epilepsy, anxiety, depression, bipolar disorder, etc. As these conditions might carry different risks for the pregnancy, independent of the medications prescribed, it is important to be able to distinguish the reason for their prescribing. Moreover, there are limited data on the safety of use of pregabalin and gabapentin during pregnancy. The project will be divided into three parts: 1. The methodological study aims to develop a general conceptual framework to disentangle the different indications of medications in large healthcare data sources. The methodology will be developed on medications used to treat neuropathic pain. 2. Drug utilisation study aims to characterize the prescription pattern of medications used to treat neuropathic pain among women of childbearing age and pregnant women, focusing on those with limited information regarding the safety profile during pregnancy such as pregabalin and gabapentin. The cohort study will be based on at least 11 data sources, covering 6 at least European countries:France, Finland, Norway, Italy, UK, Germany (approx. 17.7 million pregnancies.) A case-malformed control study will be also performed using the Euromedicat Central database (around 10,5 million pregnancies) 3. Drug safety study aims to assess the association between prenatal exposure to neuropathic pain medications (especially pregabalin and gabapentin) and adverse pregnancy outcomes, including major congenital anomalies, stillbirth, preterm birth, low birth weight, small for gestational age, and long-term neurodevelopmental outcomes. Women aged between 15 and 49 y, from 1 January 2006 to the most recent date of each data source where medications and outcomes data are available wll be studied.

Study status

Ongoing
Research institutions and networks

Institutions

Ulster University
United Kingdom (Northern Ireland)
First published:
20/03/2024
InstitutionEducational Institution
University of Bordeaux
France
First published:
01/02/2024
InstitutionEducational Institution
University of Swansea Wales, UK, University of Ferrara Emilia Romagna, Italy, EUROCAT Ulster University, UK, Institute for prevention Research and epidemiology Leipniz, Germany, University of Bordeaux Bordeaux, France

Networks

ConcepTION
First published:
01/02/2024
Network

Contact details

Christine Damase-Michel

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

IMI ConcePTION
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable