A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Eisai Clinical Trials

Protocol # E2007-A001-206

Study Overview

Study Compound: E2007

Drug Name: perampanel

Registry #: NCT00144690, 2005-004199-18

Trial Period: Mar 2005 - Feb 2007

Indication: Epilepsy

Primary Endpoint:
1. To determine the maximum tolerated dose (MTD) of E2007 given bid or qd in patients with refractory partial-onset seizures (including secondarily generalized seizures)

Population
Males and females 18 Years to 70 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
Czechia, Germany, Lithuania, Spain, Sweden, United Kingdom, United States See moreSee less

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

Krauss GL, Bar M, Biton V, Klapper JA, Rektor I, Vaiciene-Magistris N, Squillacote D, Kumar D. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand. 2012 Jan;125(1):8-15. doi: 10.1111/j.1600-0404.2011.01588.x. Epub 2011 Aug 29.

Maguire M. Response to “Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?”. Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

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