Eisai Clinical Trials

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to Less Than 18 Years of Age) With Inadequately Controlled Partial-onset Seizures

E2007-G000-235

Study Overview

E2007
perampanel
NCT01161524, 2010-018518-56
Sep 2010 - Nov 2014
Epilepsy

1. Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study) [Time Frame: Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward)]

  • Males and females 12 Years to 18 Years (Child, Adult)

  • Completed

  • Phase 2

  • Australia, Belgium, Czechia, Hungary, India, Korea, Republic of, Latvia, Poland, Spain, Thailand, United States See more

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

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.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR