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Study on the Effectiveness and Safety of Perampanel for Children with Epilepsy

Verified siteRegistered drugNo placebo
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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 perampanel in children with epilepsy. Epilepsy is a condition that affects the brain and causes repeated seizures, which are sudden bursts of electrical activity in the brain. The study aims to evaluate how effective and safe perampanel is when used alongside other antiepileptic medications that the children are already taking. Perampanel is available in two forms for this study: as a 2 mg film-coated tablet and as a 0.5 mg/ml oral suspension, both of which are taken by mouth.

The purpose of the study is to see if perampanel can help reduce the frequency of seizures in children with epilepsy. The study will involve children from 1 month to less than 18 years old. Participants will receive perampanel in addition to their current epilepsy medications. The study will last for up to 52 weeks, during which the children will be monitored to see if there is a reduction in the number of seizures they experience. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

Throughout the study, researchers will collect information on how well the children tolerate perampanel and any side effects they may experience. The goal is to determine if perampanel is a safe and effective option for managing seizures in children with epilepsy. This study is important because it could lead to better treatment options for children who suffer from this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be assessed to ensure they meet the eligibility criteria. This includes being between 1 month and less than 18 years old and having a diagnosis of childhood epilepsy.

    The participant must have experienced at least 4 seizures in the 4 weeks prior to the second visit and be on stable doses of 1 to 4 approved antiepileptic drugs.

  2. Step 2

    Treatment initiation

    The participant will begin treatment with perampanel, which is administered orally. The form of the medication can be either a film-coated tablet or an oral suspension.

    The dosage and frequency will be determined by the study protocol and adjusted based on the participant's response and tolerance.

  3. Step 3

    Core study maintenance period

    During this period, the effectiveness of perampanel will be evaluated by measuring the reduction in seizure frequency. The goal is to achieve at least a 50% reduction in seizures compared to the baseline.

    Participants will continue to take their current antiepileptic medications alongside perampanel.

  4. Step 4

    Extension phase

    Participants who complete the core study may enter an extension phase where the long-term safety and effectiveness of perampanel will be further assessed.

    The extension phase will continue to monitor seizure frequency and any side effects experienced by the participant.

  5. Step 5

    End of study

    The study is estimated to conclude by December 23, 2026. At the end of the study, a final assessment will be conducted to evaluate the overall impact of perampanel on seizure control and participant safety.

    Participants will receive guidance on the continuation or adjustment of their epilepsy treatment following the study's conclusion.

Who can join the trial?

5 criteria

  • The participant can be a boy or girl, aged from 1 month to less than 18 years for one group, or from 1 month to less than 2 years for another group. Babies younger than 1 year must have been born at least 36 weeks after conception.
  • The participant must have been diagnosed with **epilepsy**. For one group, this includes a specific type called **pediatric epileptic syndrome**. For the other group, it includes **partial-onset seizures (POS)**, which are seizures that start in one part of the brain, with or without spreading to other parts. The diagnosis should be confirmed by medical history and an **EEG** test, which checks the brain's electrical activity.
  • The participant must have had at least 4 seizures in the 4 weeks before the second visit. For one group, all types of seizures except simple POS without movement are counted. For the other group, only certain types of POS are counted, including those with movement, complex POS, and complex POS that spread to other parts of the brain.
  • The participant should not have a worsening cause of epilepsy, confirmed by medical examination or brain imaging tests like **MRI**, **CT**, or **ultrasound** (for those under 1 year old).
  • The participant must be taking stable doses of 1 to 4 approved **anti-epileptic drugs (AEDs)**. If using medical marijuana, it counts as one of the AEDs, but it cannot be the only one unless it is approved in the country where the study is conducted. The doses should be stable for at least 4 weeks (or 2 weeks for those under 6 months old) before the first visit. Only one of the AEDs can be an **enzyme-inducing AED**, which includes specific drugs like carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of epilepsy than the one being studied, which is Childhood Epilepsy, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The study is for children aged 2 years and older.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent change in their epilepsy medication cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
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Investigated drugs

Perampanel is being studied as an additional treatment for children with epilepsy. The goal is to see how effective it is in reducing the frequency of seizures. This medication is given to children aged from 1 month to less than 18 years, and the study aims to find out if it can help decrease the number of seizures by at least 50% over a 28-day period.

What is already known about the treatment

Perampanel – Perampanel is administered orally, typically in tablet form, and is used as an additional treatment for childhood epilepsy. It is currently being studied in clinical trials to assess its effectiveness and safety in children aged 1 month to less than 18 years. The main therapeutic indication for Perampanel is to reduce seizure frequency in pediatric patients with epilepsy. At the molecular level, Perampanel works by blocking certain receptors in the brain that are involved in the transmission of electrical signals, which helps to prevent seizures. It is classified as an antiepileptic drug.

Investigated diseases

Childhood Epilepsy – This condition is characterized by recurrent seizures in children, which are sudden bursts of electrical activity in the brain. These seizures can vary in type and severity, affecting different parts of the brain and leading to various symptoms such as convulsions, loss of consciousness, or unusual behaviors. The progression of childhood epilepsy can differ greatly among individuals, with some experiencing frequent seizures and others having them less often. Over time, the pattern of seizures may change, and some children may outgrow the condition. The impact on a child's development and daily life can vary, depending on the frequency and severity of the seizures.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-507794-17-00Protocol codeE2007-G000-236Estimated enrolment89 patientsSponsorEisai Limited

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