Clinical trial NCT00675025: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Down Syndrome
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-05-08
Enrollment: 117
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Visit 1 (baseline); Early Termination Visit (Week 36)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Little Rock
country: United States
facility: Child Neurology Associates, PC
state: Arkansas
city: Los Angeles
country: United States
facility: Midwest Children's Health Research Institute
state: California
city: Oakland
country: United States
facility: Children's Hospital and Research Center at Oakland
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Pediatric Pharmacology Research Unit
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Pediatrics, P.C.
state: Colorado
city: Fort Myers
country: United States
facility: Neufeld Medical Group, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center
state: Florida
city: Miami
country: United States
facility: Phoenix Children's Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Studies Centers, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Northwest Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Road Runner Research
state: Georgia
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Saint Mary's Health Care
state: Michigan
city: Grand Rapids
country: United States
facility: Washington University School of Medicine
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Northwest Clinical Research Center
state: Missouri
city: Lincoln
country: United States
facility: Meridien Research
state: Nebraska
city: Voorhees
country: United States
facility: Clinical Research Center of New Jersey
state: New Jersey
city: Durham
country: United States
facility: Division of Genetics and Developmental Behavior
state: North Carolina
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Toledo
country: United States
facility: Valko and Associates
state: Ohio
city: Tulsa
country: United States
facility: Office of Lazlo Mate
state: Oklahoma
city: Charleston
country: United States
facility: Medical Univ of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Houston
country: United States
facility: Down Syndrome Clinic of Houston
state: Texas
city: San Antonio
country: United States
facility: Alamo City Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Community Research Foundation
state: Texas
city: Bellevue
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Washington
Study officials:
References: