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
NCT ID: NCT00675025
Last Updated: 2021-03-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
117 participants
INTERVENTIONAL
2008-04-04
2008-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prior Donepezil-DB
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.
Donepezil hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Interventions
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Donepezil hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of study E2020-A001-219 (NCT00570128 \[also known as A2501059\]) with no ongoing seroius adverse events and no severe drug reactions.
Exclusion Criteria
* 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.
10 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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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
Medical Univ of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Down Syndrome Clinic of Houston
Houston, Texas, United States
Alamo City Clinical Research, LLC
San Antonio, Texas, United States
Community Research Foundation
San Antonio, Texas, United States
Neuropsychiatric Research Center of Southwest Florida
Bellevue, Washington, United States
Countries
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Other Identifiers
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A2501060
Identifier Type: OTHER
Identifier Source: secondary_id
E2020-A001-220
Identifier Type: -
Identifier Source: org_study_id
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