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Brief Title: Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Study ID: NCT00688376
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
Detailed Description: This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.
Minimum Age: 6 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
, Stanford, California, United States
, Miami, Florida, United States
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, Saint Louis, Missouri, United States
, New Brunswick, New Jersey, United States
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Road Runner Research Ltd., San Antonio, Texas, United States
, Cordoba Capital, Provincia De Cordoba, Argentina
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Sydney, New South Wales, Australia
, Westmead, Sydney, New South Wales, Australia
, Calgary, Alberta, Canada
, Antonio Varas, Providencia Santiago, Chile
, Santa Maria, Providencia Santiago, Chile
, Vandoeurvre Les Nancy, , France
, Villejuif, , France
, Koeln, , Germany
, Amsterdam, , Netherlands
, Groningen, , Netherlands
, Rotterdam, , Netherlands
, Utrecht, , Netherlands
, Palma de Mallorca, , Spain
, Valencia, , Spain
, Sutton, Surrey, United Kingdom