Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Lennox-Gastaut Syndrome (LGS) Clinical Trial

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Status Terminated

Clinical Trial Summary

This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

Clinical Trial Description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of perampanel as adjunctive therapy in participants with inadequately controlled seizures associated with LGS. The study will consist of 3 phases: Prerandomization (4 to 8 weeks), Randomization (18 weeks), and an Extension A (52 weeks). An additional Extension B with open-label treatment will be available for optional participation to participants who reside in Japan and in countries where an expanded access program (EAP) cannot be implemented or has not yet been implemented. ;

Related Conditions & MeSH terms

• Lennox Gastaut Syndrome
• Lennox-Gastaut Syndrome (LGS)
• Seizures
• Syndrome

• NCT number: NCT02834793
• Study type: Interventional
• Source: Eisai Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: December 13, 2016
• Completion date: July 19, 2021