Eisai Clinical Trials
Study Overview
E2007
perampanel
NCT02914314, 2013-005391-17
Feb 2017 - Apr 2023
Epilepsy
1. Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants [Time Frame: Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)]
2. Dose Normalized Maximum (Peak) Steady-state Concentration (Cmax,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants [Time Frame: Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4)]
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Males and females 1 Month to 4 Years (Child)
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Completed -
Phase 2
Latvia, 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