An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
Eisai Inc.
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).
Description
This study will consist of a Core Study, Extension Phase A and Extension Phase B. 1. Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks). 2. Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study. 3. Extension Phase B will only be for participants who…
Eligibility
- Age range
- 0–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants. 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. * Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2). * Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit. * Absence of any progressive cause of epilepsy that has been confirmed cl…
Interventions
- DrugPerampanel Oral Suspension
Perampanel oral suspension.
- DrugPerampanel Tablet
Perampanel tablet.
Locations (49)
- Phoenix Childrens HospitalPhoenix, Arizona
- Center For NeurosciencesTucson, Arizona
- David Geffen School of Medicine at UCLALos Angeles, California
- Childrens Hospital ColoradoAurora, Colorado
- Nemours Foundation Alfred Dupont Children's HospitalWilmington, Delaware
- Nicklaus Children's HospitalMiami, Florida