A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

We are looking for boys and girls between the ages of one month and 18 years old to take part. For some children, specifically those with a different type of seizure, the age range is from one month to under two years old. All children must have been diagnosed with epilepsy and be having at least four seizures over a four-week period before the study starts, and their epilepsy shouldn't be getting worse due to another underlying condition.

Participants must already be taking between one and four other epilepsy medicines, and the doses of these medicines need to have been stable for at least four weeks (or two weeks for babies under six months old) before joining the study. If a child is taking cannabis-based medicine that is prescribed for epilepsy, this would count as one of their four medicines.

There are also reasons why someone might not be able to join. For example, if they've had seizures that weren't really epilepsy (sometimes called 'pseudo-seizures') in the last five years, or if they've had a very serious seizure that needed a hospital stay in the last six months. Also, if they have a mental health condition that would make it difficult to take part safely, they might not be eligible. The medical team will check all these details carefully to make sure the study is right for each child.

If you decide to take part, your child will first go through a screening period for about four weeks. During this time, the medical team will make sure your child is suitable for the study and note down their current seizure activity. After that, the main study begins, which lasts about 23 weeks. This period includes an initial 10 weeks where the dose of the study medicine, perampanel, will be slowly increased, followed by a 13-week period where your child will be on a stable dose.

After the main study, there's an option to continue into an 'Extension Phase A' for another 33 weeks, plus a four-week follow-up period. Everyone who finishes the main study can choose to join this extension phase. There's also a further 'Extension Phase B' for participants in certain countries, mainly if perampanel isn't yet available there and the doctor believes the child is still benefiting from the treatment. Throughout these phases, your child will have regular check-ups, and the doctors will monitor their seizures and general health. You will also be asked to keep a record of your child's seizures.