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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00675025
• Other study ID #: E2020-A001-220
• Secondary ID: A2501060
• Status: Terminated
• Phase: Phase 2
• Start date: April 4, 2008
• Est. completion date: December 15, 2008

Study information

• Verified date: March 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: December 15, 2008
• Est. primary completion date: November 13, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Down Syndrome
• Syndrome

Intervention

Drug:
• Donepezil hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

Locations

Country	Name	City	State
United States	Road Runner Research	Atlanta	Georgia
United States	Neuropsychiatric Research Center of Southwest Florida	Bellevue	Washington
United States	Medical Univ of South Carolina	Charleston	South Carolina
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	Division of Genetics and Developmental Behavior	Durham	North Carolina
United States	Hurley Medical Center	Flint	Michigan
United States	Neufeld Medical Group, Inc.	Fort Myers	Florida
United States	Saint Mary's Health Care	Grand Rapids	Michigan
United States	Washington University School of Medicine	Grand Rapids	Michigan
United States	Down Syndrome Clinic of Houston	Houston	Texas
United States	Rocky Mountain Pediatrics, P.C.	Lakewood	Colorado
United States	Meridien Research	Lincoln	Nebraska
United States	Child Neurology Associates, PC	Little Rock	Arkansas
United States	Midwest Children's Health Research Institute	Los Angeles	California
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	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Children's Hospital and Research Center at Oakland	Oakland	California
United States	University of California, Irvine Medical Center	Orange	California
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Northwest Clinical Research Center	Saint Louis	Missouri
United States	Regions Hospital	Saint Paul	Minnesota
United States	Clinical Studies Centers, LLC	Saint Petersburg	Florida
United States	Alamo City Clinical Research, LLC	San Antonio	Texas
United States	Community Research Foundation	San Antonio	Texas
United States	UCSD Pediatric Pharmacology Research Unit	San Diego	California
United States	Valko and Associates	Toledo	Ohio
United States	Office of Lazlo Mate	Tulsa	Oklahoma
United States	Clinical Research Center of New Jersey	Voorhees	New Jersey
United States	Northwest Clinical Research Center	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)