Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

• Status: Terminated
• Trial end date: 2008-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborator: Pfizer
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Diagnosis of Down syndrome (established during study E2020-A001-220).

• Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no ongoing seroius adverse events and no severe drug reactions.

Exclusion Criteria:

• Weight less than 20 kg.

• Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.

• No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.

• Females of childbearing potential who are not practicing an effective means of birth control.