Home › Trials › NCT04015141

Evaluating Perampanel for Treating 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

PHASE2 · Eisai Inc. · NCT04015141

This study is testing if adding the medication perampanel can help children with epilepsy have fewer seizures and stay safe while using it.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment100 (estimated)
Ages1 Month to 18 Years
SexAll
SponsorEisai Inc. (industry)
Locations49 sites (Phoenix, Arizona and 48 other locations)
Trial IDNCT04015141 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of perampanel as an adjunctive therapy for children with pediatric epileptic syndrome and partial-onset seizures. It consists of a core study with a pretreatment phase followed by a treatment period, which includes titration and maintenance phases. Participants who complete the core study may enter two extension phases to continue treatment. The study will measure the responder rate based on seizure frequency during the maintenance period.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to less than 18 years diagnosed with pediatric epileptic syndrome or partial-onset seizures.

Not a fit: Patients with progressive causes of epilepsy or those not currently on stable doses of approved antiepileptic drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency in children with epilepsy.

How similar studies have performed: Other studies have shown promise in using perampanel for epilepsy, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Phoenix, Arizona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pediatric Epileptic Syndrome, Partial-onset Seizures, Partial-onset seizures, Pediatric epileptic syndrome, Epilepsy, Childhood epilepsy, Epilepsy in children, Refractory seizures

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.