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AMPA Receptor Antagonist

Perampanel for Childhood Epilepsy

UZ Brussel, Brussel, Belgium

Targeting 2 different conditionsPerampanel Oral Suspension +1 morePhase 2RecruitingResearch Sponsored by Eisai Inc.

Eligibility Criteria Checklist

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

Must have

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.

Diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2)

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Uptreatment 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

No Placebo-Only Group

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.

Eligible Conditions

Pediatric Epilepsy
Partial Seizures

Eligibility Criteria

Inclusion Criteria

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

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Cohort 1 includes children from 1 month to less than 18 years old. Cohort 2 includes children from 1 month to less than 2 years old. Babies under 1 year old must have been at least 36 weeks along when they were born.

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You have been diagnosed with epilepsy in childhood or epilepsy with partial-onset seizures, with or without spreading to the whole body.

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You had 4 or more seizures in the 4 weeks before the study starts.

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You don't have a condition that's making your epilepsy worse, like a brain problem confirmed by a doctor or brain scan.

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You are taking a specific number of approved medications for epilepsy, including medical marijuana. The doses of these medications must be stable for a certain period of time before the study.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

514 Previous Clinical Trials

154,590 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 d 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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