Status:
TERMINATED
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
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Down Syndrome
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
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 hydroc...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00675025
Start Date
April 4 2008
End Date
December 15 2008
Last Update
March 29 2021
Active Locations (31)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Child Neurology Associates, PC
Little Rock, Arkansas, United States, 72205
3
Midwest Children's Health Research Institute
Los Angeles, California, United States, 90048
4
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609