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

Phase 3 Terminated 101 enrolled Eisai Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2016-12-13
Primary completion: 2021-05-26
Completion: 2021-07-19

Outcome

Missed primary endpoint

Stopped: “Sponsor's decision”

registry p = 0.107; Median Difference (Net) -19.3 (95% CI -49.2 to 4.8) NCT02834793 ↗

Publications

Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Perampanel	Small molecule	8 mg	—