Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Trial ID or NCT#
NCT00688376
Status
NOT RECRUITING
Purpose
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.
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
Eligibility Criteria
Ages Eligible for Study: 6 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Exclusion Criteria:
- Subjects who meet any of the following criteria will be excluded from the study: 1. Inability to perform the required tests (for example, because of aphasia, motor deficits affecting the dominant hand, or mental retardation). 2. Motor coordination not sufficient, according to tests to be conducted at the time of screening. 3. Recurrence of cancer. If this happens, the subject will have to withdraw from the study. 4. Mental retardation/developmental disability. 5. Certain medications, such as methylphenidate, are not allowed during the study. 6. Major depression. 7. Problems with the digestive tract that could affect the subject's ability to absorb the study drug. 8. Hypersensitivity to a chemical class known as piperidine derivatives. 9. Certain other medical conditions as determined by clinical staff. 10. Alcoholism, drug abuse, or organic brain disease other than that caused by the cancer or its treatment. 11. Pregnancy, nursing, or unwillingness to undergo pregnancy testing if requested by clinical staff. 12. 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. 13. If sexually active, unwillingness to use birth control (males and females). 14. Plans for certain types of elective surgery that would occur while the study is in progress. 15. Plans for travel or other events that would interfere with the study schedule. 16. Active treatment with another investigational drug within 3 months of the screening visit.
Investigator(s)
Paul Graham Fisher, MD
Neuro-oncologist,
Pediatric neurologist
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Contact us to find out if this trial is right for you.
Contact
Jennifer Lew
6507254318
View on ClinicalTrials.gov
