CASTLE TRIAL v1.0
Research type
Research Study
Full title
Randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention in treatment naive children with rolandic epilepsy
IRAS ID
250324
Contact name
Deb Pal
Contact email
Eudract number
2018-003893-29
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected.
As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child’s thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, we do not know if it’s better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning.
A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, we still don’t know if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out.
In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, we have developed a sleep training plan for children with epilepsy and would like to find out whether following the sleep training plan results in less seizures than using no sleep training at all.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0452
Date of REC Opinion
12 Apr 2019
REC opinion
Favourable Opinion