Study identification

PURI

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

EU PAS number

EUPAS1000000212

Study ID

1000000212

Official title and acronym

ADEPT: The utilisation of antiseizure medications in pregnant women, other women of childbearing potential, and men: a multi-database study from 7 European countries

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 pregnant women, other women of childbearing potential, and men using data from 9 electronic healthcare databases in 7 European countries. This main objective has the following sub-objectives:
1. To estimate the annual incidence and prevalence rate of ASM use in women (12-55 years old) and men (≥12 years old) of childbearing potential;
2. To describe treatment duration, discontinuation, and treatment switches of ASMs to other ASMs or alternative medications and polytherapy in women of childbearing potential and men;
3. To estimate pre-pregnancy ASM use, and initiation and continuous use of ASMs during pregnancy period;
4. To estimate pre-pregnancy, early and late discontinuation of ASMs, treatment switches to other ASMs or alternative medications and polytherapy among pregnant women;
5. 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 over 63 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

Ongoing
Research institutions and networks

Institutions

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:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

Study protocol_ADEPT Obj 1_D2_v3.0_clean version.pdf

English (909.06 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable