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, EU CTR 2010-018518-56
Oct 2010 - Jul 2013
Epilepsy
To compare the short-term effect of perampanel on cognition to placebo by using the Cognitive Drug Research (CDR) System when administered as an adjunctive therapy in adolescents (12 to less than 18 years of age) with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures).

  • Males and females (age 12 to less than 18 years)

  • Completed

  • Phase 2

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

Results

CSR Synopsis

No download available

Lay Summary

No download available

Publication reference citation

Meador KJ, Yang H, Pina-Garza J, Laurenza A, Kumar D, Wesnes KA. Cognitive effects of adjunctive perampanel for partial-onset seizures: A randomized trial. Epilepsia 2016 02;57(2):243-25. DOI: 10.1111/epi.13279

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.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR