Last updated on September 2017

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures


Brief description of study

This is an open-label, multicenter study with an extension phase to evaluate the safety and tolerability of an perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic seizures (PGTC).

Detailed Study Description

This is a multicenter, open-label, single-arm study in children (ages 4 to less than 12 years) with inadequately controlled POS or PGTC. The study will consist of a Core Study and Extension Phase. The Core Study will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of a 4-week Screening/Baseline Period. The Treatment Phase will consist of 3 periods: up to 11-week Titration Period (dose titration on the basis of individual clinical response and tolerability), 12-week Maintenance Period (continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and 4-week Follow-up Period (only for those participants not rolling over into the Extension Phase). The Extension Phase will consist of a 29-week Maintenance Period and a 4-week Follow-up Period. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in the Extension Phase of the study. During the Maintenance Period of the Extension Phase, all participants will continue with their optimal perampanel dose (i.e., dose level that they completed on during the Core Study). Participants who do not continue in the Extension Phase or those who prematurely discontinue from the study will enter a 4-week Follow-up Period.

Clinical Study Identifier: NCT02849626

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University of Arkansas For Medical Sciences
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