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



Status:Terminated
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:10 - 17
Updated:10/14/2017
Start Date:April 2008

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An Open-Label Study To Evaluate 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

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.

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.

Inclusion Criteria:

- Diagnosis of Down syndrome (established during study E2020-A001-220).

- Completion of study E2020-A001-219 (also known as A2501059) with no ongoing SAEs 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.
We found this trial at
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101 The City Drive South
Orange, California 92868
714-456-7890
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1 Hurley Plaza
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3100 SW 62nd Ave
Miami, Florida 33155
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Miami Children's Hospital Welcome to Miami Children
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747 52nd St
Oakland, California 94609
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3756 Roswell Road Northeast
Atlanta, Georgia 30342
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14271 Metropolis Avenue
Bellevue, Washington 98004
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
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411 Trent Drive
Durham, North Carolina 27710
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3660 Central Avenue
Fort Myers, Florida 33912
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200 Jefferson Avenue Southeast
Grand Rapids, Michigan 49503
(616) 685-5000
Saint Mary's Health Care Mercy Health Saint Mary's is part of Mercy Health
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15 Michigan Street Northeast
Grand Rapids, Michigan 49503
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6621 Fannin Street
Houston, Texas 77030
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Lakewood, Colorado 80214
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Little Rock, Arkansas 72205
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Los Angeles, California 90048
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3100 Southwest 62nd Avenue
Miami, Florida 33155
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3100 Southwest 62nd Avenue
Miami, Florida 33155
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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4950 Childrens Place
Saint Louis, Missouri 63110
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640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
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19026 Stone Oak Parkway
San Antonio, Texas 78258
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San Antonio, Texas 78258
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San Diego, California 92123
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St. Petersburg, Florida 33709
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Toledo, Ohio 43606
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Voorhees, New Jersey 08043
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West Palm Beach, Florida 33407
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