Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000212

EU PAS number

EUPAS1000000212

Study ID

1000000212

Official title and acronym

The utilisation of antiepileptics in men and women of childbearing age, and pregnant women in Europe (ADEPT)

DARWIN EU® study

No

Study countries

Finland
France
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

This will be a drug utilisation study for antiseizure medications (ASMs) in men and women of childbearing age, and pregnant women using data from 9 electronic healthcare databases in Europe. This main objective has the following sub-objectives:
a. To estimate the annual incidence and prevalence rate of ASM use in men (≥12 years old) and women of childbearing age (12-55 years old);
b. To describe treatment duration, discontinuation, and treatment switches of ASMs to other ASMs or alternative medications and polytherapy in men and women of childbearing age;
c. To estimate incidence and prevalence of specific ASM use in the one year prior to and during the pregnancy period;
d. To estimate and compare discontinuation, treatment switches to other ASMs or alternative medications and polytherapy among women in the 1-year prior to pregnancy or during first, second and third pregnancy trimesters;
e. To estimate dose changes of ASMs in women prior to and during pregnancy.

We will leverage data, human resources, expertise, methods, and infrastructures that are available in the EU PE&PV, ConcepTION, and VAC4EU networks. For this specific purpose, we included 9 pre-selected data sources from 7 countries whose data quality will be characterised using available INSIGHT tools (level 1-2 quality checks) that operate on the ConcePTION CDM structure. The source population comprises 48 million persons. This study will be conducted under the ENCePP code of conduct. The protocol, reports, code lists, clinical definition forms and phenotype algorithms, results and programs will be made publicly available with digital object identifiers in line with FAIR principles.

Study status

Planned
Research institution and networks

Institutions

INSPIRE
Italy
First published:
01/02/2024
Institution
Other

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
ORCID number:
0000-0003-1360-2388
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable