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An international study to investigate and optimise the safety of discontinuing valproate in young men and women with epilepsy



grant amount:


lead investigator:

Dr Gashirai Mbizvo


-Professor Tony Marson


University of Liverpool


For many people with epilepsy, sodium valproate is effective at controlling seizures. However, there are restrictions about when it can be used by women as it can cause harm to the unborn child during pregnancy. Soon, there will be restrictions for men too, as new evidence shows harm to children born from men taking valproate. There is some evidence that when people stop taking valproate, they may have an increased risk of seizures, falls, injuries, and depression.

"This study will benefit people living with epilepsy as a substantial number of young men and women may soon be invited by their doctor to consider coming off their valproate owing to concerns about the harm it may cause to their unborn child in future. Whilst this is an important risk to consider, these young men and women are likely to also ask what the risks of stopping the valproate are for their own health. This study will provide immediate evidence to help doctors answer that question. It will also empower the young men and women with a tool to help them select the safest alternative antiseizure medication to replace the valproate.”

The Study

This study will make use of anonymised research data that has already been collected from over 20,000 people with epilepsy who took valproate between 2015-2018. The team will compare people who discontinued valproate and started taking lamotrigine, levetiracetam or no new medication. The team will look to see which of these groups had the highest risks of death, hospital admission, seizures, falls, poor mental health and other outcomes.

This comparison will give rise to a statistical tool that can be used to predict which antiseizure medications used to replace valproate are associated with the lowest risks. The tool will take personal circumstances into account, such as age, sex, type of epilepsy, and other health conditions.


This research will provide vital information about the safest ways for people to stop taking valproate. The resulting tool will help doctors and people with epilepsy to see which antiseizure medications are the safest alternative to valproate for them.