A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome

Eisai Clinical Trials

Protocol # E2023-A001-304

Study Overview

Study Compound: E2023

Drug Name: lorcaserin

Registry #: NCT04572243

Trial Period: Sep 2020 - Aug 2024

Indication: Dravet Syndrome

Primary Endpoint: 1. Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks) [Time Frame: Baseline to Week 14]

Population
Males and females 2 Years and older (Child, Adult and Older Adult)
Study Status
Terminated
Study Phase
Phase 3
Countries
Canada, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Data Sharing

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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