Perampanel for Pediatric Epilepsy
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive perampanel during the Core Study, including a 10-week titration period and a 13-week maintenance period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension Phase A
Participants continue treatment with perampanel for an additional 33 weeks, followed by a 4-week follow-up period
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
Perampanel is already approved in European Union, United States for the following indications:
- Partial-onset epilepsy (with or without secondary generalized seizures)
- Primary generalized tonic-clonic seizures
- 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.
Lead Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University