NCT02094053

A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this double-blind, placebo-controlled, comparative study and open-label extension study is to confirm the efficacy and safety of E2020 in subjects with Down syndrome having regression symptoms and disabled activities of daily living.

Detailed description

This is a multicenter, randomized, double-blind, multiple-dose (two doses), placebo-controlled, parallel-group comparative study followed by an open-label extension study of E2020 in subjects with Down syndrome having regression and disabled ADL. A total of 60 subjects will be randomized to one of three dosing groups (at 1:1:1) to receive 3 mg of E2020, 5 mg of E2020, or placebo for 24 weeks based on their total scores of Body Functionality Checklist, sex, and study site as the allocation factors. This study consists of Pre-randomization Phase (4 weeks), Double-blind Phase (28 weeks), and Extension Phase (24 weeks). The Double-blind Phase includes a 24-week treatment period plus a 4-week transition period.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DRUG	E2020-Donepezil hydrochloride	3 mg of E2020 (oral) once daily, for 24 weeks
DRUG	E2020-Donepezil hydrochloride	5 mg of E2020 (oral) once daily, for 24 weeks
DRUG	Placebo	placebo (oral) once daily, for 24 weeks

Timeline

• Start date: 2013-09-12
• Primary completion: 2016-09-16
• Completion: 2017-04-21
• First posted: 2014-03-21
• Last updated: 2017-08-22

Locations

10 sites across 1 country: Japan