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
- Registration Number
- NCT00675025
- Lead Sponsor
- Eisai Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 117
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prior Donepezil-DB Donepezil hydrochloride (Aricept) 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.
- Primary Outcome Measures
Name Time Method Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scores Visit 1 (baseline); Early Termination Visit (Week 36) VABS-II/PCRF assessed participant's adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant's behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Phoenix Children's Hospital
🇺🇸Miami, Florida, United States
UCSD Pediatric Pharmacology Research Unit
🇺🇸San Diego, California, United States
Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, 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
Neufeld Medical Group, Inc.
🇺🇸Fort Myers, Florida, United States
Clinical Studies Centers, LLC
🇺🇸Saint Petersburg, Florida, United States
Northwest Clinical Research Center
🇺🇸Saint Louis, Missouri, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Road Runner Research
🇺🇸Atlanta, Georgia, United States
Clinical Research Center of New Jersey
🇺🇸Voorhees, New Jersey, United States
Meridien Research
🇺🇸Lincoln, Nebraska, United States
Office of Lazlo Mate
🇺🇸Tulsa, Oklahoma, United States
Division of Genetics and Developmental Behavior
🇺🇸Durham, North Carolina, United States
Valko and Associates
🇺🇸Toledo, Ohio, United States
Medical Univ of South Carolina
🇺🇸Charleston, South Carolina, 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
Rocky Mountain Pediatrics, P.C.
🇺🇸Lakewood, Colorado, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Washington University School of Medicine
🇺🇸Grand Rapids, Michigan, United States