Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Impairment

In brief

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.

Key facts

Study ID

NCT00688376

Run by

Eisai Inc.

People needed

72

Starts

2008-07-02

Expected to finish

2009-05-26

Last updated by the study team

2022-01-05

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from the study:
• Inability to perform the required tests (for example, because of aphasia, motor deficits affecting the dominant hand, or mental retardation).
• Motor coordination not sufficient, according to tests to be conducted at the time of screening.
• Recurrence of cancer. If this happens, the subject will have to withdraw from the study.
• Mental retardation/developmental disability.
• Certain medications, such as methylphenidate, are not allowed during the study.
• Major depression.
• Problems with the digestive tract that could affect the subject's ability to absorb the study drug.
• Hypersensitivity to a chemical class known as piperidine derivatives.
• Certain other medical conditions as determined by clinical staff.
• Alcoholism, drug abuse, or organic brain disease other than that caused by the cancer or its treatment.
• Pregnancy, nursing, or unwillingness to undergo pregnancy testing if requested by clinical staff.
• Pregnancy, lactation or plans to become pregnant, or unwilling to take a screening Beta-human chorionic gonadotropin (ßhCG) test if a female >10 years of age.
• If sexually active, unwillingness to use birth control (males and females).
• Plans for certain types of elective surgery that would occur while the study is in progress.
• Plans for travel or other events that would interfere with the study schedule.
• Active treatment with another investigational drug within 3 months of the screening visit.

Where it is running

• Study site — Stanford, California, United States
• Study site — Miami, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Road Runner Research Ltd. — San Antonio, Texas, United States
• Study site — Cordoba Capital, Córdoba Province, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Sydney, New South Wales, Australia
• Study site — Westmead, Sydney, New South Wales, Australia
• Study site — Calgary, Alberta, Canada
• Study site — Antonio Varas, Providencia Santiago, Chile
• Study site — Santa María, Providencia Santiago, Chile
• Study site — Vandoeurvre Les Nancy, France
• Study site — Villejuif, France
• Study site — Cologne, Germany
• Study site — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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