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A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
NCT04015141 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Perampanel Oral Suspension
- DRUG Perampanel Tablet
Study Locations (20)
Florida
- Nicklaus Children's Hospital — Miami
- Pediatric Neurology PA — Orlando
- Pediatric Epilepsy and Neurology Specialists — Tampa
Arizona
- Phoenix Childrens Hospital — Phoenix
- Center For Neurosciences — Tucson
Georgia
- PANDA Neurology — Atlanta
- Meridian Clinical Research-(Savannah Georgia) — Savannah
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
- Dayton Children's Hospital — Dayton
Texas
- Child Neurology Consultants of Austin — Austin
- Road Runner Research Ltd — San Antonio
California
- David Geffen School of Medicine at UCLA — Los Angeles
Colorado
- Childrens Hospital Colorado — Aurora
Delaware
- Nemours Foundation Alfred Dupont Children's Hospital — Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2027-12-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04015141
The ClinicalTrials.gov registry entry for NCT04015141 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pediatric Epileptic Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Perampanel Oral Suspension is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04015141 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04015141 about?
NCT04015141 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy". 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).
What is the current status of trial NCT04015141?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2019-05-31. Estimated completion is 2027-12-23.
What conditions does trial NCT04015141 study?
This clinical trial studies the following conditions: Pediatric Epileptic Syndrome, Partial-onset Seizures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04015141?
The interventions under investigation include: Perampanel Oral Suspension (DRUG), Perampanel Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04015141?
This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04015141 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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