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Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
This study is ongoing, but not recruiting participants.
First Received: May 28, 2008   Last Updated: April 16, 2009   History of Changes
Sponsors and Collaborators: Eisai Medical Research Inc.
Eisai Limited
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00688376
  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.


Condition Intervention Phase
Attention Impairment
Drug: Donepezil hydrochloride
Drug: Placebo
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: E 2020 Donepezil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Change in the TOVA-CPT (Test of Variables in Attention - Continuous Performance Test) reaction time variability measure (administered to subjects). [ Time Frame: Screening to week 12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Paired Assoc. Learning Test, Woodcock Johnson Decision Speed Test, Woodcock Johnson Mathematics Fluency; Go/No-Go Task (for subjects); Conners' Parent Rating Scale-Revised (S); Behavioral Rating Inventory of Executive Functioning (parent/legal guardian). [ Time Frame: Screening to Week 12. ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Donepezil hydrochloride
During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight. During the Blinded Extension Phase, all subjects will receive active treatment (donepezil).
2: Placebo Comparator Drug: Placebo

During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.

During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).


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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. The subject must have received at least one cycle of chemotherapy and/or cranial radiation, and must have completed this treatment at least one year before screening takes place for entry into this study.
  2. Subjects may be male or female; age range: 6 - 17.5 years; weight ≥ 20 kg. They must be physically healthy and able to move about, with or without aids, must be living in the community, and must have adequate motor skills as shown by tests that will be given at the time of screening. The subject's eyesight and hearing must be good enough to allow cooperation with tests and physical examinations. Additionally, they must be able to swallow tablets.
  3. There must be subjective complaints by subject and/or parent of difficulties in school or other daily activities, possibly related to impairments in attention. These difficulties must have emerged after treatment for cancer and must still be present 12 months after cessation of treatment. There must also be objective evidence for this impairment, as shown by a test that will be given to the subject at the time of screening.
  4. The IQ must be >70 according to tests that will be given at the time of screening.
  5. The first language in which the subject learned to read and write must be one that uses Roman lettering (a, b, c, etc.) and Arabic numerals (1, 2, 3, etc.).
  6. The subject must not have previously taken any drugs in the class known as cholinesterase inhibitors.
  7. A parent or legal guardian must be available who is willing and able to complete all of the outcome measures, to administer medications, and to accompany the subject to the required clinic visits.
  8. Subjects with diabetes or thyroid disease may still be eligible if certain medical requirements are satisfied.
  9. Female subjects who could become pregnant must undergo pregnancy testing and must agree to use contraception.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688376

  Show 31 Study Locations
Sponsors and Collaborators
Eisai Medical Research Inc.
Eisai Limited
Investigators
Study Director: Margaret Moline, Ph.D Eisai Medical Research Inc.
  More Information

No publications provided

Responsible Party: Eisai Medical Research Inc. ( Margaret Moline, PhD )
Study ID Numbers: E2020-G000-333
Study First Received: May 28, 2008
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00688376     History of Changes
Health Authority: United States: Food and Drug Administration;   European Union: European Medicines Agency

Keywords provided by Eisai Medical Research Inc.:
Attention
cancer
chemotherapy
donepezil
acetylcholinesterase
inhibitor

Study placed in the following topic categories:
Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Donepezil
Cholinergic Agents

Additional relevant MeSH terms:
Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Donepezil
Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009