Eisai Clinical Trials
Study Overview
E2007
perampanel
NCT01393743, 2011-000265-12, JapicCTI-121774, jRCT2080211732
Sep 2011 - Nov 2015
Epilepsy
1. Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study) [Time Frame: Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)]
2. 50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study) [Time Frame: Baseline (4 or 8 weeks) and Maintenance (13 weeks)]
3. 50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase - (for Extension Phase) [Time Frame: Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase]
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Males and females 12 Years and older (Child, Adult, Older Adult)
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Completed -
Phase 3
Australia, Austria, China, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Serbia, United States See moreData 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 not 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