If you’re familiar with rolandic epilepsy, you and your paediatrician might be faced with the choice of starting regular antiepileptic medication or alternatively you might be advised that it is better not to treat but just manage each seizure as it comes. Your child will “grow out” of them in time, so… Perhaps you are apprehensive about the idea of your child being treated with drugs? Or perhaps you are scared about seeing your child going through another seizure? All these factors can influence our opinion about what is best for the child.
Why do health professionals not have an agreed view about what is best – treatment or no treatment? Well, quite often we don’t actually know which is best. Much of medical knowledge is guided by previous practice, not all of which is based on scientific evidence. And sometimes, what we thought we “knew” can be proven wrong by scientific evidence.
In the case of rolandic epilepsy, some children end up with no drug treatment, and many are treated with standard antiepileptic drugs like carbamazepine, which is recommended by the NICE guidelines.
However, while carbamazepine is very effective at preventing seizures in RE, it may also have negative impacts on learning. A newer drug called levetiracetam that is licensed for children might be just as effective but without impacts on learning. So one question that we want to answer through this trial is to see whether it is best not to treat, to use the NICE recommended drug, or to use a newer drug. In a clinical trial, we can compare the effects of newer treatments with standard treatments and get better evidence about how common or serious side effects are.
But that’s not the whole story. Again, if you’re familiar with rolandic epilepsy, you’ll know that the seizures often come at night or early in the morning. They are usually very sensitive to sleep and may occur either at night, or during a nap in the back of the car. They often follow a disturbed night like after a party or during holiday travel. So what if we could prevent seizures by improving the quality of sleep? A novel idea, eh? Sleep can be improved through practice, without the need of drugs. There are behavioural interventions to help toddlers go to sleep, but there is nothing out there that takes into account the special considerations of young people with epilepsy and their parents. You’ll find that we are developing a custom package for this.
Who are we & what are we doing?
We have designed this clinical trial in such a way that everyone has an equal chance of being treated with one of the drug/non-drug options, as well as having a 50:50 chance of trying our sleep package. Just like with the drugs, we don’t actually know if our sleep package will actually help young people with epilepsy get to sleep.
So by taking part, you will be able to help young people with epilepsy and their parents to decide whether and which drugs are best for them, and if better sleep can prevent seizures too! You will receive loads of information about the trial through this website, and from your paediatrician or epilepsy specialist nurse. We are also preparing a short video to outline the main issues and decisions so check back soon!
The CASTLE clinical trial is now ready to launch! All necessary initial approvals (Ethical, MHRA and HRA) for the study have been received and we intend to begin recruitment in June 2019.
Please also see this document for FAQS about CASTLE