Study of Cenobamate for Children with Partial-Onset Seizures

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What is this study about?

This clinical trial is focused on studying Partial-Onset Seizures in children and teenagers aged 2 to less than 18 years. The treatment being tested is a medication called Cenobamate, also known by its code name YKP3089. This medication is given as an oral suspension, which means it is a liquid that is taken by mouth. The purpose of the study is to understand how the body processes Cenobamate in young patients with these types of seizures.

Participants in the study will receive Cenobamate in increasing doses to see how their bodies handle the medication over time. The study will involve both single doses and multiple doses to gather comprehensive information. Throughout the study, the safety and tolerability of Cenobamate will be closely monitored, which means researchers will watch for any side effects or reactions to the medication. Additionally, the study will collect information on how often seizures occur while taking the medication.

The study aims to provide valuable insights into the use of Cenobamate for treating Partial-Onset Seizures in children and teenagers. By understanding how the medication works in younger patients, researchers hope to improve treatment options for those affected by this condition. Participants will be under careful observation to ensure their safety and well-being throughout the study period.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes reviewing the diagnosis of epilepsy with partial-onset seizures and ensuring that the participant is currently on stable doses of 1 to 3 approved antiepileptic drugs (AEDs).

Participants must have a history of treatment failure with at least 2 AEDs and meet specific weight criteria based on their cohort.

2 consent and assent

Written informed consent must be signed by the participant, legal guardian, or legally authorized representative. Age-appropriate assent is obtained for children and adolescents who are cognitively able.

3 baseline evaluation

A baseline evaluation is conducted, including seizure assessments, safety laboratory tests, and physical and neurological examinations. This step ensures that all participants are ready to begin the study.

4 medication administration

Participants receive cenobamate as an oral suspension. The dosage is determined based on the participant’s weight and cohort assignment. The study involves both single and multiple dosing to assess how the body processes the medication.

5 pharmacokinetic assessments

Blood samples are collected to measure the levels of cenobamate in the plasma. This helps to understand how the medication is absorbed, distributed, and eliminated by the body.

6 safety and tolerability monitoring

Participants are monitored for any adverse effects. This includes regular checks of vital signs, electrocardiograms, and other safety laboratory tests. The acceptability and palatability of the medication are also assessed.

7 efficacy evaluation

Seizure frequency is recorded using a seizure diary to evaluate the effectiveness of cenobamate in reducing seizures.

8 study completion

The study is estimated to end by March 31, 2026. Upon completion, participants undergo a final evaluation to assess overall outcomes and any long-term effects of the medication.

Who Can Join the Study?

The patient must have a diagnosis of epilepsy with partial-onset seizures. These are seizures that start in one part of the brain. The diagnosis should have been made at least 6 months before the study starts, based on medical history and an electroencephalogram (EEG), which is a test that measures brain activity.
The patient can be a boy or girl, aged 2 to less than 18 years old at the time of giving consent to join the study.
The patient must weigh within certain limits based on their age group. For example, in one group, boys and girls should weigh between 16-63 kg, in another group between 13-28 kg, and in another group between 10-20 kg.
There must be a signed consent form from the patient, their legal guardian, or a legally authorized representative before joining the study. If the child is old enough to understand, they will also be asked to agree to join the study.
The patient should currently be taking 1 to 3 approved antiepileptic drugs (AEDs), which are medicines used to control seizures. The doses of these medicines should not have changed for at least 4 weeks before the study starts. If the patient has a vagal nerve stimulator (VNS), which is a device used to help control seizures, it will not count as one of the 3 medicines.
The doctor must believe that the patient’s parents or caregivers can accurately report the patient’s seizures during the study. The patient must also be able to take the study medicine.
If the patient has a vagal nerve stimulator implanted, it must have been in place for at least 5 months before the study starts, and its settings should not have changed for 30 days before the study.
If the patient is on a ketogenic diet, which is a special high-fat, low-carbohydrate diet sometimes used to help control seizures, the diet must have been stable for at least 30 days before the study and should remain stable during the study.

Who Cannot Join the Study?

Patients who do not have partial onset seizures cannot participate. Partial onset seizures are a type of seizure that starts in one specific area of the brain.
Children younger than 2 years old or older than 18 years old are not eligible to join the study.
Participants who are not able to follow the study procedures or take the study medication as required will be excluded.
Individuals with other medical conditions that might interfere with the study or pose a risk to their health if they participate will not be allowed to join.
Patients who are currently participating in another clinical trial or have recently participated in one may not be eligible.
Anyone who has had an allergic reaction to the study medication or similar medications in the past will be excluded.
Pregnant or breastfeeding females cannot participate in the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Semmelweis University	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	04.01.2025
Spain	Not recruiting	04.01.2025

Trial locations

Investigated drugs:

Cenobamate

Cenobamate (YKP3089) is a medication being studied for its effects on children and teenagers who experience partial-onset seizures. This study aims to understand how the body processes the medication when given in different amounts over time. Cenobamate is being tested to see if it can help reduce the frequency or severity of seizures in young patients.

Investigated diseases:

Partial seizures

Partial Onset Seizures – These seizures begin in one specific area of the brain and can affect various functions depending on the region involved. They may cause unusual sensations, movements, or experiences, such as a sudden feeling of fear or joy, or a change in the way things look, smell, feel, taste, or sound. As the seizure progresses, it can spread to other parts of the brain, potentially leading to a generalized seizure. The individual may remain aware during the seizure or experience a change in consciousness. These seizures can vary in duration and frequency, and their impact can differ from person to person.

Trial ID:

2024-514045-11-00

Protocol code:

YKP3089C039

NCT ID:

NCT04903314

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Cenobamate for Children with Partial-Onset Seizures

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