NCT02834793

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Lennox-Gastaut Syndrome (LGS)

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive matching placebo in Randomization phase.
DRUG	Perampanel	Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B.

Timeline

• Start date: 2016-12-13
• Primary completion: 2021-05-26
• Completion: 2021-07-19
• First posted: 2016-07-15
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

65 sites across 7 countries: United States, Australia, Belgium, Czechia, India, Japan, South Korea

Regulatory

• FDA-regulated drug study