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NCT04015141Active, not recruitingPhase 2

A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
27 May 2019
Start date
31 May 2019
Primary completion date
6 Apr 2027
Lead sponsor
Eisai Inc.
Diseases
Epilepsy
NCT number
NCT04015141
EU CT number
2023-507794-17-00
EudraCT number
2018-004456-38

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • From 31 May 2019 to the primary completion date, 6 Apr 2027
  • 27 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
  • Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.

Other

  • Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).

Who the study is looking for

  • 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.

Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Coordinator of this site? Confirm its status
BrusselsBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Fakultni nemocnice Brno
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Universitaetsklinikum Jena KöR
Coordinator of this site? Confirm its status
JenaGermanyCompleted
Klinikum der Universitaet Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyCompleted
Hospital Universitario de Navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Robert Debre University Hospital
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
Coordinator of this site? Confirm its status
RennesFranceActive, not recruiting
Hopital Des Enfants
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Toulouse Cedex 9FranceActive, not recruiting
Childrens Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Child Neurology Consultants of Austin
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AustinUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Children's Hospital of Michigan
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Northeast Regional Epilepsy Group
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
David Geffen School of Medicine at UCLA
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Nicklaus Children's Hospital
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MiamiUnited StatesUnknown status
Children's Specialty Group
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NorfolkUnited StatesUnknown status
Children's Hospital of Richmond at VCU - CHoR-PIN
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RichmondUnited StatesUnknown status
Road Runner Research, Ltd
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San AntonioUnited StatesUnknown status
Meridian Clinical Research-(Savannah Georgia)
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SavannahUnited StatesUnknown status
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Pediatric Epilepsy and Neurology Specialists
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Wake Forest Baptist Medical Center - PPDS
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.