Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000417

EU PAS number

EUPAS1000000417

Study ID

1000000417

Official title and acronym

Paternal exposure to valproate and the risk of neurodevelopmental disorders in children

DARWIN EU® study

No

Study countries

Norway
Taiwan

Study description

The use of valproate by male patients during the three months before conception has recently drawn attention due to concerns about a potential increase in the risk of neurodevelopmental disorders (NDDs) in their offspring. Following a review of pertinent data, the European Medicines Agency's (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has advised caution in prescribing these medicines. However, this recommendation is based on limited, unpublished data and the findings have not yet been replicated.
Therefore, this study aims to investigate the association between paternal exposure to valproate and the risk of NDDs in two distinct populations, Norway and Taiwan, to provide more comprehensive evidence.

Study status

Ongoing
Research institutions and networks

Institutions

National Taiwan University

Contact details

Fei-Yuan Hsiao

Primary lead investigator
ORCID number:
0000-0003-1660-9120
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding

More details on funding

This study was supported by the International Alliance for PharmacoGenetic Epidemiology Excellence (iAPOGEE) project funded by the Norwegian Research Council (grant No 322176) and the National Science and Technology Council (NSTC 113-2314-B-002-167-MY3) of Taiwan. The funders had no role in the study design; the collection, analysis, and interpretation of data; the writing of the report; or the decision to submit the article for publication.
Study protocol
Initial protocol

Paternal exposure to valproate and the risk of neurodevelopmental disorders in children.pdf

English (628.7 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable