Study identification

PURI

https://redirect.ema.europa.eu/resource/84554

EU PAS number

EUPAS50789

Study ID

84554

Official title and acronym

DARWIN EU® Drug utilisation of valproate-containing medicinal products in women of childbearing potential

DARWIN EU® study

Yes

Study countries

Belgium
Finland
Germany
Netherlands
Spain
United Kingdom

Study description

Valproic acid/valproate-containing medicines are first-line treatment for epilepsy, and used as second-line treatments for the treatment of bipolar disorder and migraine prevention. Valproic acid/valproate is a teratogen, with prenatal exposure carrying a substantial risk of neurodevelopmental impairment and congenital malformations in the child. Therefore, its use in women of childbearing age is restricted to prevent valproate exposure during conception and pregnancy.
The European Medicines Agency commissioned this DARWIN EU© study to estimate the incidence rate and prevalence of VPA use and alternative treatments, and to characterise patient-level valproate use in women between aged ≥12 to ≤55 12 and 55 years of age from 2010 to 2022.

Study status

Finalised
Research institution and networks

Institutions

Oxford University UK

Networks

Contact details

Annika Jodicke

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D2.2.3_DARWIN_EU_Study_Protocol_C1-002_v2.0_Clean_EUPAS

English (965.28 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