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

Stopped early · Phase 2

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT00675025

Run by

Eisai Inc.

People needed

117

Starts

2008-04-04

Expected to finish

2008-12-15

Last updated by the study team

2021-03-29

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Child Neurology Associates, PC — Little Rock, Arkansas, United States
• Midwest Children's Health Research Institute — Los Angeles, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• UCSD Pediatric Pharmacology Research Unit — San Diego, California, United States
• Rocky Mountain Pediatrics, P.C. — Lakewood, Colorado, United States
• Neufeld Medical Group, Inc. — Fort Myers, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center — Miami, Florida, United States
• Phoenix Children's Hospital — Miami, Florida, United States
• Clinical Studies Centers, LLC — St. Petersburg, Florida, United States
• Northwest Clinical Research Center — West Palm Beach, Florida, United States
• Road Runner Research — Atlanta, Georgia, United States
• Hurley Medical Center — Flint, Michigan, United States
• Saint Mary's Health Care — Grand Rapids, Michigan, United States
• Washington University School of Medicine — Grand Rapids, Michigan, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Northwest Clinical Research Center — St Louis, Missouri, United States
• Meridien Research — Lincoln, Nebraska, United States
• Clinical Research Center of New Jersey — Voorhees Township, New Jersey, United States
• Division of Genetics and Developmental Behavior — Durham, North Carolina, United States
• Metrohealth Medical Center — Cleveland, Ohio, United States
• Valko and Associates — Toledo, Ohio, United States
• Office of Lazlo Mate — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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