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

Condition(s) targeted: Down Syndrome

Intervention: Donepezil Hydrochloride (Aricept) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Anita Murthy, PharmD, Study Director, Affiliation: Eisai Inc.

Overall contact:
Yvonne Noble, Phone: 201-746-2036, Email: yvonne_noble@eisai.com

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.

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

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

Primary outcome: Physical and neurological exams, clinical labs, ECG, Conmeds, Adverse Events, Serious Adverse Events.

Secondary outcome: Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form.

Detailed 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.

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Yvonne Noble, Phone: 201-746-2036, Email: yvonne_noble@eisai.com

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States; Recruiting

Child Neurology Associates, PC, Little Rock, Arkansas 72205, United States; Recruiting

University of California, Irvine Medical Center, Orange, California 92868, United States; Recruiting

Midwest Children's Health Research Institute, Los Angeles, California 90048, United States; Recruiting

UCSD Pediatric Pharmacology Research Unit, San Diego, California 92123, United States; Active, not recruiting

Children's Hospital and Research Center at Oakland, Oakland, California 94609, United States; Recruiting

Rocky Mountain Pediatrics, P.C., Lakewood, Colorado 80214, United States; Recruiting

Phoenix Children's Hospital, Miami, Florida 33155, United States; Active, not recruiting

Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center, Miami, Florida 33155, United States; Active, not recruiting

Clinical Studies Centers, LLC, St. Petersburg, Florida 33709, United States; Recruiting

Northwest Clinical Research Center, West Palm Beach, Florida 33407, United States; Recruiting

Miami Children's Hospital, Miami, Florida 33155-3009, United States; Active, not recruiting

Neufeld Medical Group, Inc., Fort Myers, Florida 33912, United States; Recruiting

Road Runner Research, Atlanta, Georgia 30342, United States; Recruiting

Saint Mary's Health Care, Grand Rapids, Michigan 49503, United States; Recruiting

Washington University School of Medicine, Grand Rapids, Michigan 49503, United States; Active, not recruiting

Hurley Medical Center, Flint, Michigan 48503, United States; Recruiting

Regions Hospital, Saint Paul, Minnesota 55101-2595, United States; Recruiting

Northwest Clinical Research Center, Saint Louis, Missouri 63110, United States; Recruiting

Meridien Research, Lincoln, Nebraska 68504, United States; Recruiting

Clinical Research Center of New Jersey, Voorhees, New Jersey 08043, United States; Recruiting

Division of Genetics and Developmental Behavior, Durham, North Carolina 27710, United States; Recruiting

Metrohealth Medical Center, Cleveland, Ohio 44109, United States; Recruiting

Valko and Associates, Toledo, Ohio 43606, United States; Recruiting

Office of Lazlo Mate, Tulsa, Oklahoma 74104, United States; Active, not recruiting

Medical Univ of South Carolina, Charleston, South Carolina 29425, United States; Recruiting

Vanderbilt Children's Hospital, Nashville, Tennessee 37232-9225, United States; Recruiting

Alamo City Clinical Research, LLC, San Antonio, Texas 78258, United States; Active, not recruiting

Down Syndrome Clinic of Houston, Houston, Texas 77030, United States; Active, not recruiting

Community Research Foundation, San Antonio, Texas 78258, United States; Recruiting

Neuropsychiatric Research Center of Southwest Florida, Bellevue, Washington 98004, United States; Recruiting

Starting date: April 2008
Last updated: August 21, 2008