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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.

NCT02094053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-22

No results posted yet for this study

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.

Conditions

  • Down Syndrome

Interventions

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

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-12
Primary Completion
2016-09-16
Completion
2017-04-21

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094053 on ClinicalTrials.gov