A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Phase of Trial: Phase III
Latest Information Update: 04 Dec 2018
At a glance
- Drugs Perampanel (Primary)
- Indications Partial epilepsies
- Focus Registrational; Therapeutic Use
- Acronyms EXPLORE-306
- Sponsors Eisai Inc
- 04 Dec 2018 Results presented in an Eisai Inc media release.
- 04 Dec 2018 According to an Eisai Inc media release, post-hoc analysis from this study were presented at the American Epilepsy Society Annual Meeting.
- 28 Sep 2018 According to an Eisai Inc media release, based on the safety data of Study 311 and Study 232 and the efficacy data from three phase 3 pivotal studies (EXPLORE-304, 305, 306) , the US FDA has approved drug FYCOMPA (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History