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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00688376
• Date of registration: 28/05/2008
• Prospective Registration: Yes
• Primary sponsor: Eisai Inc.
• Public title: Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
• Scientific 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
• Date of first enrolment: July 2, 2008
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00688376
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Canada, Chile, France, Germany, Netherlands, Spain, United Kingdom, United States

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Attention Impairment

Intervention(s)

Drug: Placebo

Drug: Donepezil hydrochloride

Primary Outcome(s)

Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change From Baseline in the TOVA-CPT "D-prime" Standard Score (SS) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale [Time Frame: Baseline and Week 12]

Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12 [Time Frame: Baseline, Weeks 6 and 12]

Secondary ID(s)

E2020-G000-334

E2020-G000-333

2007-005435-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eisai Limited

Results

• Results available: Yes
• Date Posted: 27/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00688376