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NCT04015141 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
A Phase 2 study of Partial-onset Seizures and Pediatric Epileptic Syndrome, sponsored by Eisai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT04015141 is a Phase 2 study of Partial-onset Seizures and Pediatric Epileptic Syndrome that is actively recruiting participants, run by Eisai. The registered enrollment target is 100 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT04015141, a Phase 2 study of Partial-onset Seizures and Pediatric Epileptic Syndrome, is actively recruiting participants, sponsored by Eisai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 287 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Partial-onset Seizures appearing as the primary indexed condition, and to 2 interventions - of which Perampanel Oral Suspension is the first listed.
NCT04015141 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Arizona, Georgia.
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: Partial-onset Seizures, Pediatric Epileptic Syndrome.
What interventions are being tested in trial NCT04015141?
The interventions under investigation include: Perampanel Oral Suspension (DRUG), Perampanel Tablet (DRUG).
Who is sponsoring clinical trial NCT04015141?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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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