Official Title: “An Open-Label Study To Evaluate 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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Donepezil Hydrochloride (Aricept)
  • Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Physical and neurological exams, clinical labs, ECG, Conmeds, Adverse Events, Serious Adverse Events.
  • Time Frame: Visit 1 (baseline); Phone Visit (weeks 2,4,6); Visit 2.
    Safety Issue?: Yes

Secondary Measures

• Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form.
  • Time Frame: Visit 1 (baseline); Visit 4 (week 42).
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of Down syndrome (established during study E2020-A001-220).
• Completion of study E2020-A001-219 (also known as A2501059) with no ongoing SAEs 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eisai Inc.

Overall Clinical Trial Officials and Contacts

Anita Murthy, PharmD Study Director Eisai Inc.  

Overall Contact: Yvonne Noble 201-746-2036 yvonne_noble@eisai.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675025

Study ID Number: E2020-A001-220

ClinicalTrials.gov Identifier: NCT00675025

Health Authority: United States: Food and Drug Administration