129
Participants
Start Date
November 16, 2007
Primary Completion Date
September 5, 2008
Study Completion Date
September 5, 2008
Donepezil HCl
Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day \[mL/day\]) orally for participants with body weight (BW) 20 and less than (\<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to \<50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (\>=) 50 kg liquid formulation (1 milligram per 1 milliliter \[1 mg/1 mL\]) (titrated to 0.1 to 0.2 milligram per kilogram per day \[mg/kg/day\] based on BW).
Placebo
Liquid formulation matched to active treatment for oral administration.
Duke University Medical Center, Durham
Medical University of South Carolina, Division of Genetics and Developmental and Behavioral Pediatrics, Charleston
Child Neurology Associates, PC, Atlanta
Community Research Foundation, Miami
Miami Children's Hospital, Brain Institute, Miami
Lazlo J. Mate, MD, West Palm Beach
Meridien Research, St. Petersburg
Neuropsychiatric Research Center of South West Florida, Fort Myers
Valko and Associates, Toledo
Metrohealth Medical Center, Division of Psychiatry, Cleveland
Medical Genetics and Neuro Development Center, Zionsville
Hurley Medical Center, Flint
Saint Mayr's Health Care, Grand Rapids
Washington University School of Medicine, Division of Genetics and Genomic Medicine, St Louis
Midwest Children's Health Research Institute, LLC, Lincoln
Clinical Study Centers, L.L.C., Little Rock
Down Syndrome Clinic of Houston, Houston
Alamo City Clinical Research, LLC, San Antonio
Road Runner Research, San Antonio
Rocky Mountain Pediatrics, Lakewood
Phoenix Children's Hospital, Phoenix
Neufeld Medical Group, Inc., Los Angeles
UCSD Pediatric Pharmacology Research Unit, San Diego
University of California, Irvine Medical Center, Department of Pediatrics, Orange
Children's Hospital and Research Center at Oakland, Oakland
Northwest Clinical Research Center, Bellevue
Miami Children's Hospital, Clinical Research Center, Miami
Regions Hospital, Saint Paul
Clinical Research Center of New Jersey, Voorhees Township
Tulsa Clinical Research LLC, Tulsa
Vanderbilt Children's Hospital, Nashville
Collaborators (1)
Pfizer
INDUSTRY
Eisai Inc.
INDUSTRY