RecruitingOBSERVATIONAL

The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children

This research is investigating two common medicines, levetiracetam and phenytoin, used to stop long-lasting seizures in children. These seizures, known as status epilepticus, are a medical emergency in young people and can sometimes have long-term effects. Currently, there's a need to find the most effective and safest treatment. The study aims to find out if levetiracetam works as well as phenytoin in stopping these seizures and preventing them from coming back, but with potentially fewer side effects. It includes children aged 3 months to 17 years who have had long seizures and have already been given a first type of medicine (benzodiazepines) that didn't work. By comparing these two treatments, doctors hope to improve care for children experiencing this serious condition.

At a glance

Status

Recruiting

Sponsor

University Hospital, Strasbourg, France

Enrolment target

151

Start

16 Nov 2023

Estimated completion

16 May 2025

Epilepsy in Children

What is this study about?

When a child has a seizure that lasts a long time – more than 5 minutes – it's called status epilepticus. This is a medical emergency that needs quick treatment to stop the seizure. While it can be very worrying for parents, doctors work hard to limit any immediate or long-term problems it might cause. When the first type of medicine given (called benzodiazepines) doesn't stop the seizure, doctors need to use other treatments.

This study is looking at two medicines often used in these situations: levetiracetam and phenytoin. Both are used to try and stop these long seizures. The main goal of this research is to see if levetiracetam is at least as effective as phenytoin at stopping the seizure and preventing it from happening again soon after. Importantly, the researchers also want to find out if levetiracetam has fewer side effects or is generally better tolerated by children.

The findings from this study are important because they could help doctors make better decisions about which medicine to use when a child has a long seizure. The aim is always to provide the best possible care with the fewest complications for children affected by this serious condition.

Key takeaways

This study looked at treatments for long-lasting seizures in children.
It compared two medicines: levetiracetam and phenytoin.
The goal was to see which medicine was more effective and had fewer side effects.
Data from children aged 3 months to 17 years was included.
The findings could help improve future care for children with these seizures.

Who may be eligible?

This study included children who were between 3 months and 17 years old. They were considered for the study if they had received a first treatment (benzodiazepines) for a long seizure, and it didn't work. After that, they would have been given either levetiracetam or phenytoin as a second treatment.

All children in the study were treated at one of the hospitals taking part between November 2019 and May 2023. This study mostly looked at information already collected from patients during their normal care.

A child would not have been included if their parents or guardians had clearly said they didn't want their child's anonymised information to be used for research purposes after being given all the details about the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was your child between 3 months and 17 years old?
Did they have a long seizure (status epilepticus)?
Did they receive either levetiracetam or phenytoin after a first medicine didn't work?
Were they treated at a participating hospital between November 2019 and May 2023?

Answer every question to see your result.

What does participation involve?

This particular study looked back at information from children who had already received treatment. This means that if your child was included, they would have been given one of the two medicines (levetiracetam or phenytoin) as part of their standard medical care for a long seizure at the time. Your child would not have had extra visits, assessments, or medicine specific to this research. Their medical records were simply reviewed with your consent to help answer the study's questions.

Potential risks and benefits

Because this study looked at existing medical records, there were no direct risks to the children involved, as they were not given new treatments or procedures specifically for this research. The potential benefit is that the findings could help doctors in the future choose the best and safest medicine for children experiencing long seizures, potentially improving outcomes for many. Parents always have the right to say no to their child's information being used for research, even if it's anonymised.

Locations (1)

Service pédiatrie 1 - CHU de Strasbourg - France
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is status epilepticus?

It's a medical emergency where a seizure lasts longer than 5 minutes and needs quick treatment to stop it.

What two medicines did the study compare?

The study compared levetiracetam and phenytoin.

Who was included in the study?

Children aged 3 months to 17 years who had a long seizure that didn't stop with the first line of treatment.

Why is this research important?

It helps doctors understand which medicine works best and with the fewest side effects for children with long seizures.

Did my child have extra treatments for this study?

No, this study used information from treatments children already received as part of their usual care.

How to find out more

Sarah BAER, MD

sarah.baer@chru-strasbourg.fr 33 3 88 12 63 98 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.