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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
University Hospital Jena KöR	Jena	Germany
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hopital Des Enfants	Toulouse	France
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Robert Debre University Hospital	Paris	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Kfbnwgso dkk Ugmcmrwlucce Mioyswtj Aeo	Munich	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	31.07.2019
France	Recruiting	31.07.2019
Germany	Not recruiting	31.07.2019
Spain	Recruiting	31.07.2019

Trial locations

Investigated drugs:

Perampanel

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.

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 ID:

2023-507794-17-00

Protocol code:

E2007-G000-236

NCT ID:

NCT04015141

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?