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Study on the Effectiveness and Safety of Cenobamate for Patients Aged 12 and Older with Primary Generalized Tonic-Clonic Seizures

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called cenobamate on individuals experiencing Primary Generalized Tonic-Clonic Seizures. These seizures are a type of epilepsy characterized by sudden and severe muscle contractions and loss of consciousness. The study aims to evaluate how effective and safe cenobamate is when used alongside other treatments for these seizures. Participants in the study will receive either cenobamate or a placebo, which looks like the medication but does not contain the active ingredient.

The trial involves taking cenobamate in different forms, such as tablets or an oral suspension, which is a liquid form of the medication. The study will last for several months, during which participants will be monitored to see how their seizures respond to the treatment. The goal is to determine if cenobamate can reduce the frequency of seizures and improve the quality of life for those affected by this condition.

Throughout the study, participants will have regular check-ups to assess their health and any changes in their seizure patterns. The information gathered will help researchers understand the potential benefits and any side effects of using cenobamate as an additional therapy for managing Primary Generalized Tonic-Clonic Seizures. This research is important for developing better treatment options for people living with epilepsy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to receive either cenobamate or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  2. Step 2

    Titration phase

    Participants begin with a low dose of cenobamate or placebo, starting at 12.5 mg per day. The dose is gradually increased over several weeks to reach the target dose of 200 mg per day, or the equivalent dose for adolescents.

    The medication is taken orally, in the form of film-coated tablets or oral suspension, depending on the assigned group.

  3. Step 3

    Maintenance phase

    Once the target dose is reached, participants continue to take the medication at this dose for the duration of the maintenance phase.

    The primary goal during this phase is to monitor the frequency of primary generalized tonic-clonic seizures and assess the effectiveness of the treatment.

  4. Step 4

    Follow-up

    After completing the maintenance phase, participants undergo a follow-up period to evaluate any long-term effects of the treatment.

    This includes monitoring seizure frequency and any potential side effects experienced during the trial.

Who can join the trial?

10 criteria

  • The person must be male or female and at least 12 years old.
  • If the person is on a special diet called a ketogenic diet, it should have been stable for at least 3 months before starting the study and should remain stable during the study.
  • The person, or their legal guardian, must sign a document called informed consent before joining the study. This document shows they understand the study and agree to participate. For teenagers, a simpler agreement called assent is also needed.
  • Females who can have children must agree to use a reliable form of birth control.
  • The person must have a medical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures, which are a type of seizure, possibly along with other types of generalized seizures.
  • The person must have had at least 5 PGTC seizures in the 12 weeks before the study starts.
  • The person must have had a test called an electroencephalogram (EEG) within the last 5 years or during the period before the study starts. This test checks brain activity and should show signs of a condition called idiopathic generalized epilepsy.
  • The person must have had a CT scan or MRI within the last 10 years or during the period before the study starts. These are imaging tests that should show there is no worsening cause of epilepsy.
  • The person must be taking 1 to 3 antiepileptic drugs (AEDs) with stable doses for at least 30 days before starting the study. If they are taking a type of medicine called benzodiazepines at least once a week, it counts as one of these drugs, and the dose should not change during the study.
  • If the person is using a device called a vagal nerve stimulator or deep brain stimulator, it should have been in place for at least 5 months before starting the study, and its settings should not change for 30 days before starting and during the study.

Who cannot join the trial?

8 criteria

  • Individuals who are under 12 years of age cannot participate.
  • Individuals who do not have Primary Generalized Tonic-Clonic Seizures cannot participate. These are a type of seizure that affects the whole brain and body, causing muscle stiffness and jerking movements.
  • Individuals who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Individuals who have other medical conditions that might interfere with the study cannot participate.
  • Individuals who are pregnant or breastfeeding cannot participate.
  • Individuals who are currently participating in another clinical trial cannot participate.
  • Individuals who have a history of drug or alcohol abuse cannot participate.
  • Individuals who have had an allergic reaction to the study medication or similar medications cannot participate.
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Investigated drugs

Cenobamate is a medication being studied for its effectiveness in reducing seizures in people who have primary generalized tonic-clonic seizures. It is used as an additional treatment to help control seizures in patients who are 12 years of age or older. The goal of the study is to see how well cenobamate works in comparison to a placebo, focusing on its ability to decrease the frequency and severity of these types of seizures.

What is already known about the treatment

Cenobamate – Cenobamate is administered orally, typically in tablet form, and is currently being studied in clinical trials for its effectiveness in treating primary generalized tonic-clonic seizures. It is an approved medication in some regions for the treatment of partial-onset seizures, and ongoing research is evaluating its broader applications. The main therapeutic indication for cenobamate in this trial is as an adjunctive therapy for seizures. At the molecular level, cenobamate works by modulating sodium channels and enhancing GABAergic inhibition, which helps stabilize neuronal activity. It is classified pharmacologically as an anticonvulsant.

Investigated diseases

Primary Generalized Tonic-Clonic Seizures – These seizures involve the entire brain from the onset and are characterized by a combination of muscle stiffening and rhythmic muscle contractions. They typically begin with a loss of consciousness and a sudden fall, followed by a period of muscle rigidity and then convulsions. The person may experience a postictal state afterward, which is a period of confusion or drowsiness. These seizures can occur at any age but are more common in children and young adults. They are often unpredictable and can vary in frequency and intensity. The exact cause is not always known, but they may be related to genetic factors or other underlying neurological conditions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506687-13-00Protocol codeYKP3089C025Estimated enrolment172 patientsSponsorSk Life Science Inc.

sourced from the EU Clinical Trials Register and site verification

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