An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures
Phase of Trial: Phase III
Latest Information Update: 30 Mar 2018
At a glance
- Drugs Perampanel (Primary)
- Indications Epilepsy
- Focus Adverse reactions
- Sponsors Eisai Inc
- 30 Mar 2018 According to an Eisai Inc media release, the submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 -12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.
- 30 Mar 2018 According to an Eisai Inc media release, based on the interim data of this trial and data from Study 232, the company has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for FYCOMPA CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years).
- 02 Mar 2018 This trial has been completed in Italy.