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

Eisai

Status and phase: Terminated; Phase 2

Conditions: Down Syndrome

Treatments: Drug: Donepezil hydrochloride (Aricept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675025

A2501060 (Other Identifier)

E2020-A001-220

Details and patient eligibility

About

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.

Full description

All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Enrollment: 117 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

Prior Donepezil-DB

Experimental group

Description:

All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration.

Treatment:

Drug: Donepezil hydrochloride (Aricept)