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Trial record 90 of 331 for:    DONEPEZIL

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

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ClinicalTrials.gov Identifier: NCT00452868
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : February 28, 2013
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Long-term Effects Secondary to Cancer Therapy in Children
Neurotoxicity
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Intervention Drug: Donepezil
Enrollment 14
Recruitment Details patients were registered from 9/11/2006 to 5/14/2009
Pre-assignment Details 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.
Arm/Group Title Donepezil
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Arm/Group Title Donepezil
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
13
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
12.81  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
Hide Description Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
10  (3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Donepezil
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil
Affected / at Risk (%) # Events
Total   3/11 (27.27%)    
Gastrointestinal disorders   
vomiting  1  2/11 (18.18%)  2
General disorders   
Dehydration  2  1/11 (9.09%)  1
ataxia  2  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3
2
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Donepezil
Affected / at Risk (%) # Events
Total   11    
Ear and labyrinth disorders   
Dizziness  1  1/11 (9.09%)  1
Neuropathy: cranial: CN VIII Hearing and balance  1  1/11 (9.09%)  1
Eye disorders   
Occular/Visual  1  2/11 (18.18%)  2
Gastrointestinal disorders   
Nausea  1  6/11 (54.55%)  6
Diarrhea  1  5/11 (45.45%)  5
Incontenence, anal  1  1/11 (9.09%)  1
General disorders   
Anorexia  1  5/11 (45.45%)  5
Fatigue  1  10/11 (90.91%)  10
Pain: Abdomen NOS  1  4/11 (36.36%)  4
Pain: Back  1  1/11 (9.09%)  1
Pain: Extremity-limb  1  1/11 (9.09%)  1
Infections and infestations   
Fever (in the absence of neutropenia)  1  1/11 (9.09%)  1
Infection  1  1/11 (9.09%)  1
Infection with unknown ANC: Bronchus  1  1/11 (9.09%)  1
Infection with unknown ANC: Nerv-peripheral  1  1/11 (9.09%)  1
Infection with unknown ANC: Urinary tract NOS  1  1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized: whole body  1  1/11 (9.09%)  1
Pain: Muscle  1  5/11 (45.45%)  5
Muscle weakness, generalid or specfic ara (not due to neuropathy): Left sided  1  1/11 (9.09%)  1
Nervous system disorders   
Neurology  1  2/11 (18.18%)  2
Pain: Head/headache  1  1/11 (9.09%)  1
Confusion  1  1/11 (9.09%)  1
Psychiatric disorders   
Personality/behavioral  1  1/11 (9.09%)  1
Insomnia  1  4/11 (36.36%)  4
Speech Impairment  1  1/11 (9.09%)  1
Mood Alteration: Agitation  1  1/11 (9.09%)  1
Extrapyramidal/involuntary movement/restlessness  1  1/11 (9.09%)  1
Renal and urinary disorders   
Incontinence, urinary  1  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Pain: Skin  1  1/11 (9.09%)  1
Vascular disorders   
Hemorrhag, pulmonary/upper respiratory: nose  1  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Janet Tooze
Organization: Wake Forest Baptist Health
Phone: 336-716-0286
EMail: jtooze@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00452868     History of Changes
Other Study ID Numbers: CDR0000537049
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU-91305 ( Other Identifier: Comprehensive Cancer Center of WFUHS )
CCCWFU-IRB-00000258 ( Other Identifier: WFUHS IRB )
First Submitted: March 27, 2007
First Posted: March 28, 2007
Results First Submitted: August 31, 2012
Results First Posted: February 28, 2013
Last Update Posted: September 7, 2018