Trial Outcomes & Findings for Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain (NCT NCT00452868)
NCT ID: NCT00452868
Last Updated: 2018-09-07
Results Overview
Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
14 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-09-07
Participant Flow
patients were registered from 9/11/2006 to 5/14/2009
13 unique patients were recruited, one patient twice after failing to start therapy the first time, two patients were not evaluable, leaving 11 patients for analysis.
Participant milestones
| Measure |
Donepezil
Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients \< 35 kg. And to 10 mg/day for patients \> 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
Baseline characteristics by cohort
| Measure |
Donepezil
n=13 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.81 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksDelis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Outcome measures
| Measure |
Donepezil
n=11 Participants
|
|---|---|
|
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
|
10 units on a scale
Standard Deviation 3
|
Adverse Events
Donepezil
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil
n=11 participants at risk
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
|
General disorders
ataxia
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Donepezil
n=11 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
54.5%
6/11 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 5
|
|
General disorders
Anorexia
|
45.5%
5/11 • Number of events 5
|
|
Renal and urinary disorders
Incontinence, urinary
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Personality/behavioral
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Dizziness
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
36.4%
4/11 • Number of events 4
|
|
Nervous system disorders
Neurology
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Fatigue
|
90.9%
10/11 • Number of events 10
|
|
Nervous system disorders
Pain: Head/headache
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Occular/Visual
|
18.2%
2/11 • Number of events 2
|
|
Infections and infestations
Fever (in the absence of neutropenia)
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Infection
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Speech Impairment
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Confusion
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Mood Alteration: Agitation
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Pain: Abdomen NOS
|
36.4%
4/11 • Number of events 4
|
|
General disorders
Pain: Back
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Hemorrhag, pulmonary/upper respiratory: nose
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Extrapyramidal/involuntary movement/restlessness
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Incontenence, anal
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized: whole body
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain: Muscle
|
45.5%
5/11 • Number of events 5
|
|
General disorders
Pain: Extremity-limb
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain: Skin
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC: Bronchus
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC: Nerv-peripheral
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC: Urinary tract NOS
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalid or specfic ara (not due to neuropathy): Left sided
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Neuropathy: cranial: CN VIII Hearing and balance
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place