Study Stopped
Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.
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
An Open-label Study to Evaluate the Safety of Donepezil Hydrochloride((Aricept®) for up to 1 Year in the Treatment of Cognitive Dysfunction Exhibited by Children With Down Syndrome-Follow-up to a 10-Week,Double-Blind,Placebo-Controlled Trial
2 other identifiers
interventional
117
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2008
CompletedResults Posted
Study results publicly available
March 29, 2021
CompletedMarch 29, 2021
March 1, 2021
7 months
May 7, 2008
March 29, 2013
March 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Visit 1 (baseline); Early Termination Visit (Week 36)
Study Arms (1)
Prior Donepezil-DB
EXPERIMENTALAll 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.
Interventions
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Pfizercollaborator
Study Sites (31)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Child Neurology Associates, PC
Little Rock, Arkansas, 72205, United States
Midwest Children's Health Research Institute
Los Angeles, California, 90048, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
UCSD Pediatric Pharmacology Research Unit
San Diego, California, 92123, United States
Rocky Mountain Pediatrics, P.C.
Lakewood, Colorado, 80214, United States
Neufeld Medical Group, Inc.
Fort Myers, Florida, 33912, United States
Miami Children's Hospital
Miami, Florida, 33155-3009, United States
Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center
Miami, Florida, 33155, United States
Phoenix Children's Hospital
Miami, Florida, 33155, United States
Clinical Studies Centers, LLC
St. Petersburg, Florida, 33709, United States
Northwest Clinical Research Center
West Palm Beach, Florida, 33407, United States
Road Runner Research
Atlanta, Georgia, 30342, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Washington University School of Medicine
Grand Rapids, Michigan, 49503, United States
Regions Hospital
Saint Paul, Minnesota, 55101-2595, United States
Northwest Clinical Research Center
St Louis, Missouri, 63110, United States
Meridien Research
Lincoln, Nebraska, 68504, United States
Clinical Research Center of New Jersey
Voorhees Township, New Jersey, 08043, United States
Division of Genetics and Developmental Behavior
Durham, North Carolina, 27710, United States
Metrohealth Medical Center
Cleveland, Ohio, 44109, United States
Valko and Associates
Toledo, Ohio, 43606, United States
Office of Lazlo Mate
Tulsa, Oklahoma, 74104, United States
Medical Univ of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-9225, United States
Down Syndrome Clinic of Houston
Houston, Texas, 77030, United States
Alamo City Clinical Research, LLC
San Antonio, Texas, 78258, United States
Community Research Foundation
San Antonio, Texas, 78258, United States
Neuropsychiatric Research Center of Southwest Florida
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This was an open-label trial that was terminated early by the Sponsor.
Results Point of Contact
- Title
- Eisai Medical Services
- Organization
- Eisai Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 8, 2008
Study Start
April 4, 2008
Primary Completion
November 13, 2008
Study Completion
December 15, 2008
Last Updated
March 29, 2021
Results First Posted
March 29, 2021
Record last verified: 2021-03