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New epilepsy drug shows promise for kids in early trial

NCT ID NCT04015141

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding perampanel (Fycompa) to current epilepsy medications can reduce seizures in children aged 1 month to 18 years. About 100 children with specific epilepsy syndromes or partial-onset seizures will receive the drug. The main goal is to see if at least half of the children experience a 50% or greater drop in seizure frequency.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Perampanel (also known as Fycompa), an oral medication
What this could lead to
If successful, this could provide a new add-on treatment option to help control seizures in children with epilepsy.
What could go wrong
This is an early phase 2 study with only 100 children, so results may not confirm effectiveness or safety for broader use. Side effects are possible, and the drug is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth. * Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2). * Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit. * Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging \[MRI\] scan or computed tomography \[CT\] or ultrasound \[for less than 1 year old\]). * Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than \[\<\] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed. Exclusion Criteria: * Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit. * Have a history of status epilepticus that required hospitalization within 6 months before screening visit. * Have an unstable psychiatric diagnosis that may confound participant's ability to participate in the study or that may prevent completion of the protocol specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before screening visit 1, current psychotic disorder, acute mania). * Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years. * Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed. * Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors. * Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed. * A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study). * Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure. * Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).

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Conditions

The condition(s) this trial relates to.

childhood-onset epilepsy syndrome epilepsy focal epilepsy infantile epilepsy syndrome visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Partial-onset seizures Pediatric epileptic syndrome

Contacts and locations

Locations

  • CHRU Rennes

    Rennes, France

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela, Spain

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, France

  • Centre Neurologique William Lennox

    Ottignies, Brabant Wallon, Belgium

  • Child Neurology Consultants of Austin

    Austin, Texas, 78731, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Richmond at VCU - CHoR-PIN

    Richmond, Virginia, 23298, United States

  • Children's Specialty Group

    Norfolk, Virginia, 23510, United States

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Complejo Hospitalario de Navarra

    Pamplona, Spain

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Dr. Von Haunersches Kinderspital

    Munich, Germany

  • Fakultni nemocnice Brno

    Brno, Czechia

  • Hopital Necker

    Paris, France

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhone, France

  • Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676

    Paris, France

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, Spain

  • Hôpital Pellegrin-Enfants

    Bordeaux, France

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels, Brussels Capital, Belgium

  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg, Germany

  • Meridian Clinical Research-(Savannah Georgia)

    Savannah, Georgia, 31406, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601, United States

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33607, United States

  • Road Runner Research Ltd

    San Antonio, Texas, 78249, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • UZ Brussel

    Brussels, Brussels Capital, Belgium

  • UZ Gent

    Ghent, Oost-Vlaanderen, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina, 27157, United States

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