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AMPA Receptor Antagonist

Perampanel for Pediatric Epilepsy

Phase 2

Recruiting

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of any progressive cause of epilepsy confirmed clinically or based on brain imaging

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60

Awards & highlights

Study Summary

This trial will study the effects of perampanel on seizure frequency in children with epileptic syndrome and partial-onset seizures. They will measure the 50% responder rate during the maintenance period of the study.

Who is the study for?

This trial is for children with epilepsy: Cohort 1 includes those under 18 years with pediatric epileptic syndrome, and Cohort 2 includes infants up to 2 years old with partial-onset seizures. Participants must have had at least four seizures in the last month and be on stable doses of up to four antiepileptic drugs.Check my eligibility

What is being tested?

The study tests Perampanel's effectiveness as an additional treatment for childhood epilepsy. It measures how many participants experience a significant reduction in seizure frequency during the maintenance phase using either oral suspension or tablet forms.See study design

What are the potential side effects?

Perampanel may cause dizziness, sleepiness, fatigue, irritability, falls, nausea, weight gain or loss, aggression or anger outbursts. These side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My epilepsy is not getting worse according to tests or doctor's evaluation.

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I am under 18 years old and was born after at least 36 weeks of pregnancy.

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I have had 4 or more seizures in the last month.

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I have been diagnosed with a specific type of epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study

Secondary outcome measures

Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A

Change From Baseline in the Cognitive Drug Research (CDR) Parameter at the End of the Treatment Period of Core Study and at the End of Extension Phase A

Change from Baseline in CBCL Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A

+19 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PerampanelExperimental Treatment2 Interventions

Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perampanel Tablet

2020

Completed Phase 2

~10

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

515 Previous Clinical Trials

158,871 Total Patients Enrolled

Media Library

Perampanel (AMPA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04015141 — Phase 2

Partial Seizures Research Study Groups: Perampanel

Partial Seizures Clinical Trial 2023: Perampanel Highlights & Side Effects. Trial Name: NCT04015141 — Phase 2

Perampanel (AMPA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04015141 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Perampanel Oral Suspension likely to cause harm to patients?

"While there is some data suggesting Perampanel Oral Suspension is safe, it only received a 2 because there currently no clinical trials supporting its efficacy."

Answered by AI

If a patient is under 40, do they still qualify for the research program?

"The age requirements for this particular trial are that potential participants must be between 1 month and 18 years old. Out of the 12 clinical trials, 128 focus on pediatric patients while 197 center around senior citizens."

Answered by AI

Are there any precedents for a Perampanel Oral Suspension clinical trial?

"The first clinical trial for Perampanel Oral Suspension occurred in 2017 at Stony Brook University Medical Center. To date, there have been 52 completed studies and 11 ongoing trials. A large number of these are being conducted near Hackensack, New jersey."

Answered by AI

Does this trial set a precedent for other similar trials?

"Research for Perampanel Oral Suspension began in 2017 with a 60 person trial sponsored by Eisai Inc. N/A drug approval was given following the successful completion of the initial study and, as of today, there are 11 live trials taking place in 51 cities across 9 countries."

Answered by AI

How many people are involved in this clinical trial?

"Yes, the trial is still recruiting patients. The posting on clinicaltrials.gov shows that the last edit was on 11/16/2022 and that they are looking for 100 participants from 8 different locations."

Answered by AI

In how many different places is this trial taking place?

"There are 8 available for this clinical trial including Northeast Regional Epilepsy Group in Hackensack, Pediatric Epilepsy and Neurology Specialists in Tampa, and Seattle Children's Hospital in Seattle."

Answered by AI

Are people currently being accepted into this trial?

"The listed clinical trial on clinicaltrials.gov appears to be ongoing, with the most recent update being from November 16th, 2020. This study is looking for 100 individuals at 8 different locations."

Answered by AI

If I meet the requirements, may I sign up for this experiment?

"This trial is looking for 100 individuals that experience aura and meet the following age, diagnosis, and medication requirements: between 1 month to 18 years old with a confirmed epilepsy diagnosis who are taking up to 4 approved antiepileptic drugs--one of which can be prescription medical marijuana in countries where it is not considered an illegal substance. The individual must also be stable on their current AED doses for at least 4 weeks prior to enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04015141.

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