Study on the Safety and Effectiveness of Cenobamate for Children with Focal Seizures

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a medication called cenobamate (also known by its code name YKP3089) in children who experience partial-onset seizures. Partial-onset seizures, also known as focal seizures, are a type of epilepsy where seizures start in one specific area of the brain. The study involves children aged 2 to less than 18 years who have been diagnosed with this condition.

The purpose of the study is to evaluate how well children tolerate cenobamate and to observe any side effects that may occur. Participants in the study will receive cenobamate in different forms, including oral suspension and tablets, with varying doses such as 12.5mg, 25mg, 50mg, and 100mg. The study will last for up to 12 months, during which the children will be monitored for any changes in their seizure frequency and overall health. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of cenobamate.

Throughout the study, researchers will track the number of seizures, any side effects, and changes in behavior or development. They will also assess the acceptability and taste of the medication forms. The goal is to gather information that could help improve treatment options for children with partial-onset seizures in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of partial-onset (focal) seizures and ensuring that the participant meets the age and weight requirements.

A review of current medications is performed to ensure stable doses of 1 to 3 approved antiepileptic drugs (AEDs) are being used. Any additional treatments, such as a vagal nerve stimulator, must also be stable.

2 baseline period

During the 28-day baseline period, seizure frequency is monitored. This helps establish a reference point for evaluating the effectiveness of the treatment.

3 treatment initiation

The treatment phase begins with the administration of cenobamate. The medication is available in various forms, including oral suspension and film-coated tablets, with dosages of 10mg/mL, 50mg, 25mg, 12.5mg, and 100mg.

The specific dosage and form are determined based on individual needs and medical advice.

4 titration phase

The dosage of cenobamate is gradually increased during the titration phase. This process helps identify the most effective dose while monitoring for any side effects.

5 maintenance phase

Once the optimal dose is reached, the maintenance phase begins. The participant continues to take cenobamate at this dose for the duration of the study.

Regular assessments are conducted to monitor seizure frequency, side effects, and overall health.

6 evaluation and follow-up

Throughout the study, various evaluations are performed, including neuropsychological assessments and behavior checklists, to assess the impact of the treatment.

The study aims to determine the safety and effectiveness of cenobamate in reducing seizure frequency and improving quality of life.

Who Can Join the Study?

The patient must have a diagnosis of epilepsy with partial-onset (focal) seizures. This means seizures that start in one part of the brain. The diagnosis should be confirmed by a doctor and supported by a test called an electroencephalogram (EEG), which records brain activity.
If the patient is following a ketogenic diet, which is a special high-fat, low-carbohydrate diet, it must have been stable for at least 30 days before the study starts and should remain stable during the study.
The patient can be a boy or girl, aged between 2 and less than 18 years old at the time of giving consent to participate in the study.
The patient must weigh at least 10 kilograms (about 27 pounds).
The patient should have had a brain scan, like an MRI or CT scan, within the last 10 years to rule out any worsening cause of epilepsy.
For new participants, the patient must have had at least one partial-onset seizure during a 28-day period before the study starts.
The patient should be currently taking stable doses of 1 to 3 approved antiepileptic drugs (AEDs), which are medications used to control seizures. The doses should not have changed for at least 4 weeks before the study starts. If the patient uses a vagal nerve stimulator (VNS), a device that helps control seizures, its settings should also be stable for at least 4 weeks before the study.
The doctor believes that the patient could benefit from trying the study medication.
If the patient is already part of a related study, they must continue to meet all the requirements from that study.
If the patient is taking a medication called felbamate, they must have been using it for at least 12 months and have had a stable dose for at least 60 days before the study. They should not have a history of liver problems or blood disorders caused by felbamate.

Who Cannot Join the Study?

Children younger than 2 years old cannot participate.
Children older than 18 years old cannot participate.
Children who do not have partial-onset (focal) seizures cannot participate. Partial-onset seizures are a type of seizure that starts in one specific area of the brain.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet	Budapest	Hungary
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie	Cracow	Poland
Eszak-Budai Szent Janos Centrumkorhaz	Budapest	Hungary
University Of Debrecen	Debrecen	Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza	Budapest	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Konultny dqo Unbolpghuogt Mpcgczlk Aaw	Munich	Germany
Nqumqpfcfqch Zeanfp Oujyje Zuoqfsvqol &ozrlia Ckzjnew Nbtbyqtbfs Delbvvrirj i Luvsogkl Psktqptn	Kielce	Poland
Hyqhmlgq Vbcm djcdlfst	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	03.05.2021
Hungary	Not recruiting	03.05.2021
Poland	Not recruiting	03.05.2021
Spain	Not recruiting	03.05.2021

Trial locations

Investigated drugs:

Cenobamate

Cenobamate is being studied for its safety and effectiveness in children with partial-onset (focal) seizures. This medication is intended to help reduce the frequency and severity of seizures in pediatric patients. The trial aims to assess how well children tolerate the medication and to monitor any potential side effects.

Investigated diseases:

Partial seizures

Partial-onset seizures – Partial-onset seizures, also known as focal seizures, originate in a specific area of the brain. They can affect sensory, motor, or autonomic functions, leading to symptoms such as unusual sensations, muscle twitching, or changes in behavior. These seizures may remain localized or spread to other parts of the brain, potentially evolving into generalized seizures. The progression of symptoms can vary widely among individuals, with some experiencing brief episodes and others having more prolonged or frequent occurrences. The underlying causes can include brain injury, infection, or developmental abnormalities, but often the exact cause is unknown. Understanding the specific triggers and patterns of these seizures is crucial for managing their impact on daily life.

Trial ID:

2023-506841-52-00

Protocol code:

YKP3089C040

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Cenobamate for Children with Focal Seizures

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