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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.

Must not have

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

History of status epilepticus that required hospitalization within 6 months before screening visit

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken perampanel in the last 30 days or stopped it due to side effects or it not working.

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I was hospitalized for a severe seizure within the last 6 months.

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My weight was under 4 kg at my first visit.

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My brain condition or tumor is getting worse.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Change from Baseline in Growth and Development Parameter- Sexual Maturation Assessed by Tanner Staging

+7 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 / 8Eligibility criteria met