100 Participants Needed
Eisai Inc. logo

Perampanel for Pediatric Epilepsy

Recruiting in Dayton (<99 mi)
+17 other locations
EM
Overseen ByEisai Medical Information
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Eisai Inc.
Must be taking: Antiepileptic drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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).

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop your current medications. You must be on stable doses of 1 to 4 approved antiepileptic drugs (AEDs) for at least 4 weeks before starting the trial.

What data supports the effectiveness of the drug Perampanel for pediatric epilepsy?

Research shows that Perampanel is effective in improving seizure control in children and adolescents with difficult-to-treat epilepsy, and it is generally well-tolerated. It has been used successfully as an additional treatment for epilepsy in patients aged 12 and older, helping to reduce seizures.12345

Is Perampanel safe for children with epilepsy?

Perampanel (also known as Fycompa) has been studied for safety in children and adolescents with epilepsy. It is generally considered safe, but like any medication, it can have side effects. Some studies have shown it to be safe in children as young as 7 years old, but more research is needed for younger children.45678

How is the drug Perampanel different from other treatments for pediatric epilepsy?

Perampanel is unique because it works by blocking AMPA receptors, which are involved in transmitting signals in the brain that can lead to seizures. Unlike some other epilepsy drugs, it is specifically used as an add-on treatment for partial-onset seizures in patients aged 12 and older, and it does not significantly interact with the liver enzyme system that processes many other medications.14579

Eligibility Criteria

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.

Inclusion Criteria

My epilepsy is not getting worse according to tests or doctor's evaluation.
I am under 18 years old and was born after at least 36 weeks of pregnancy.
I am on 1-4 epilepsy drugs, including possibly medical marijuana, with stable doses for the last 4 weeks.
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Exclusion Criteria

I haven't taken perampanel in the last 30 days or stopped it due to side effects or it not working.
If you have had a VNS, RNS, or DBS implanted less than 5 months ago, or if there have been changes to the settings of these devices within the last 4 weeks.
I haven't taken benzodiazepines for reasons other than epilepsy in the last month.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive perampanel during the Core Study, including a 10-week titration period and a 13-week maintenance period

23 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension Phase A

Participants continue treatment with perampanel for an additional 33 weeks, followed by a 4-week follow-up period

37 weeks

Extension Phase B

Participants in countries without commercial availability of perampanel or an EAP may continue treatment if deemed beneficial by the investigator

Treatment Details

Interventions

  • Perampanel
Trial OverviewThe 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.
Participant Groups
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.

Perampanel is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Fycompa for:
  • Partial-onset epilepsy (with or without secondary generalized seizures)
  • Primary generalized tonic-clonic seizures
🇺🇸
Approved in United States as Fycompa for:
  • Partial-onset seizures (with or without secondary generalized seizures)
  • Primary generalized tonic-clonic seizures
  • Monotherapy and adjunctive therapy for focal epilepsy (with or without secondary generalized seizures) in patients aged 4 years and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eisai Inc. logo

Eisai Inc.

Lead Sponsor

Trials
524
Recruited
161,000+
Founded
Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.
Headquarters
Woodcliff Lake, NJ, USA
Known For
Neurology and Oncology
Top Products
Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)
Lynn Kramer profile image

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno profile image

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

In a study of 62 children and adolescents with refractory epilepsy, Perampanel (PER) demonstrated a 50% response rate in reducing seizure frequency, indicating its efficacy as an add-on therapy.
The treatment was generally well-tolerated, with a retention rate of 77.4% over an average follow-up of 6.6 months, although 30.6% of patients experienced adverse events, including behavioral disturbances and dizziness.
Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies-An Italian observational multicenter study.De Liso, P., Vigevano, F., Specchio, N., et al.[2022]
In a study of 58 pediatric patients with refractory epilepsies, perampanel (PER) demonstrated a 31% response rate, with 9% achieving complete seizure control after 3 months of treatment.
The treatment was generally well-tolerated, although some patients experienced adverse effects such as reduced vigilance or fatigue (16 cases) and behavioral changes (14 cases).
Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences.Biró, A., Stephani, U., Tarallo, T., et al.[2022]
In a study of 85 patients with focal-onset seizures, low-dose perampanel (4-6 mg/day) significantly improved seizure control compared to high doses (8-12 mg/day), with a 50% responder rate of 88.6% versus 40.0%.
Perampanel was also more effective when added to first-line anti-seizure medications, achieving a 50% responder rate of 83.5% compared to 33.3% for second-line medications, and was well tolerated with dizziness being the most common side effect.
Perampanel as First Add-On Therapy in Patients with Focal-Onset Seizures in the FAME Trial: Post hoc Analyses of Efficacy and Safety Related to Maintenance Dose and Background Antiepileptic Drug Therapy.Kim, JH., Kim, DW., Lee, SK., et al.[2022]

References

Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies-An Italian observational multicenter study. [2022]
Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. [2022]
Perampanel as First Add-On Therapy in Patients with Focal-Onset Seizures in the FAME Trial: Post hoc Analyses of Efficacy and Safety Related to Maintenance Dose and Background Antiepileptic Drug Therapy. [2022]
Perampanel (Fycompa): A Review of Clinical Efficacy and Safety in Epilepsy. [2020]
Perampanel: a new add-on treatment for epilepsy. [2021]
The efficacy of perampanel in young children with drug-resistant epilepsy. [2021]
Efficacy, tolerability and safety of perampanel in children and adolescents with epilepsy: Systematic review and meta-analysis. [2023]
A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. [2022]
Perampanel. Just another anticonvulsant for partial epilepsy: no progress. [2021]