Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial Onset Seizures

This study is testing a new medicine called Cenobamate, which is being investigated to help children who experience partial onset seizures – a type of epilepsy. We want to learn more about how this medicine works inside the body of children. This includes finding out how much of the medicine stays in the blood after a single dose and after taking it multiple times. We will also be carefully checking for any side effects and how well the children tolerate the medicine. The aim is to make sure any future treatments are as safe and effective as possible for children. This is an early-stage study, meaning it's focusing on gathering important information about the medicine's behaviour.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sk Life Science Inc.

Enrolment target

Start

27 Jan 2025

Partial Onset Seizures

What is this study about?

This study is an early step in finding out more about a medicine called Cenobamate, specifically for children who have a type of epilepsy known as partial onset seizures. Epilepsy causes seizures, and partial onset seizures start in one part of the brain. The main purpose of this study is to understand how the body of a child processes Cenobamate. This means we'll be looking at how the medicine is absorbed, how long it stays in the body, and how it's removed. This information is really important because it helps doctors figure out the right amount of medicine to give to children to make sure it's safe and works well.

We will be giving children different amounts of Cenobamate to see how their bodies react, both after a single dose and after taking it for a while. This helps us understand what happens when the medicine is first introduced and what happens with regular use. The study will also keep a very close eye on the children to make sure the medicine is safe and that they tolerate it well, meaning they don't experience too many unpleasant side effects.

Even though the main focus is on how the body handles the medicine, we will also be looking at other important things. This includes carefully checking for any side effects and monitoring the children's overall health through physical and neurological exams, including checking their growth. We will also ask about whether the medicine is easy to take. Children and their families will also be asked to keep a diary of any seizures, which will give us an early idea of how well the medicine might be helping to control them. All of this information helps build a bigger picture of how useful Cenobamate might be for children with partial onset seizures in the future.

Key takeaways

This study is exploring a new medicine (Cenobamate) for children with partial onset seizures.
It aims to understand how the medicine behaves in a child's body and check its safety.
Participants will receive the study medicine and have regular health checks.
Families will help with seizure diaries and report on the medicine's ease of use.
Joining could help advance future treatments for children with epilepsy.

Who may be eligible?

This study is open to both boys and girls of all age groups who have partial onset seizures. There aren't specific age limits mentioned, so children of various ages may be considered.

However, it's important to remember that 'any to any' typically means that the doctors running the study will have specific criteria to decide if the study is right for your child. They'll need to check your child's medical history and current health carefully to make sure the study is a safe and suitable option for them.

Factors like other health conditions, other medicines your child is taking, and how severe their seizures are will all be considered. The research team will discuss all these details with you during an initial visit to see if your child can take part.

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.

Does your child have partial onset seizures?
Is your child able to come for regular hospital visits?
Are you able to help your child keep a seizure diary?
Are you comfortable with your child having blood tests and other medical checks?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will take the medicine Cenobamate as a liquid (10mg/mL). The amount given will start small and may gradually increase. They will have regular visits to the hospital or clinic. These visits will involve several assessments, such as blood tests to see how much medicine is in their body, safety checks including ECGs (heart traces), measurements like height and weight, and physical and neurological examinations. You will also need to help your child keep a diary of their seizures and note any other medicines they are taking. The team will also ask about how easy the medicine is to take. The total length of time your child would be in the study hasn't been specified here, but it would involve a period of taking the medicine and then follow-up checks.

Potential risks and benefits

Taking part in a study like this means you might be helping to find a new treatment option for children with partial onset seizures, which could benefit many in the future. While this is an early-stage study, there's always a chance that the new medicine could help your child's seizures. However, as with any medicine, there are potential risks, including side effects which could range from mild to more serious. The research team will carefully monitor your child for any problems. You will be given full details of these potential risks before you decide to take part. Remember, joining any study is completely your choice, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Hungary

Common questions

What is 'partial onset seizures'?

Partial onset seizures are a type of epilepsy where the seizure activity starts in one specific area of the brain, rather than affecting the whole brain at once.

What does a 'Phase I' study mean?

A Phase I study is usually the first time a new medicine is given to people. The main goal is to find out how safe it is and how the body handles it, rather than how well it treats the condition.

Will my child definitely get the new medicine?

Yes, in this study, all participants will receive the study medicine, Cenobamate. It's an 'open-label' study, meaning everyone knows what medicine is being given.

What are 'pharmacokinetic assessments'?

This simply means that doctors will be taking blood samples to measure how much of the medicine is in your child's body and how long it stays there. It helps them understand how the body processes the medication.

Will this study cure my child's epilepsy?

This particular study isn't designed to find a cure. Its main goal is to understand how a new medicine works in the body and check its safety for children with partial onset seizures. Any direct benefit to your child's seizures would be an early observation.