A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

Summary

This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Timeline

Start

2010-09

Primary completion

2013-06

Completion

2014-11

Outcome

Missed primary endpoint

paper CDR System Global Cognition Score (least squares mean change, -0.6 vs. 1.6; p = 0.145) PMID 26724782 ↗

Publications

• Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2.
• Pina-Garza JE, Lagae L, Villanueva V, Renfroe JB, Laurenza A, Williams B, Kumar D, Meador KJ. Long-term effects of adjunctive perampanel on cognition in adolescents with partial seizures. Epilepsy Behav. 2018 Jun;83:50-58. doi: 10.1016/j.yebeh.2018.03.029. Epub 2018 Apr 10.
• Meador KJ, Yang H, Pina-Garza JE, Laurenza A, Kumar D, Wesnes KA. Cognitive effects of adjunctive perampanel for partial-onset seizures: A randomized trial. Epilepsia. 2016 Feb;57(2):243-51. doi: 10.1111/epi.13279. Epub 2016 Jan 1.

Drugs

Indications