A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome.
Phase of Trial: Phase III
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Rufinamide (Primary) ; Antiepileptic drugs
- Indications Lennox-Gastaut syndrome; Seizures
- Focus Registrational; Therapeutic Use
- Acronyms Study 303
- Sponsors Eisai Inc
- 05 Dec 2016 Primary endpoint has not been met. (Change in Child Behavior Checklist (CBCL) Total Problems Score), as reported in an Eisai Co Ltd media release.
- 05 Dec 2016 Results published in an Eisai Co Ltd media release.
- 05 Dec 2016 According to an Eisai media release, results of this study were presented at the 2016 Annual Meeting of the American Epilepsy Society
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History