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A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism

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ClinicalTrials.gov Identifier: NCT01887132
Recruitment Status : Terminated
First Posted : June 26, 2013
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Autism Spectrum Disorders
Interventions Drug: Donepezil
Drug: Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details 5 participants signed consent. Only 4 started the study.
Arm/Group Title Open-Label Donepezil
Hide Arm/Group Description Donepezil
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Open-Label Donepezil
Hide Arm/Group Description Donepezil
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
4
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
3.2
(2.1 to 3.9)
[1]
Measure Description: Mean age of the participants at screening.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  25.0%
White
3
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Nonverbal Developmental Quotient (NVDQ)
Hide Description The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered "impaired" IQ (approximately lower than 70).
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Donepezil
Hide Arm/Group Description:
Donepezil
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: units on a scale
NVDQ for participant 1 at Baseline 51.61
NVDQ for participant 2 at Baseline 48.89
NVDQ for participant 3 at Baseline 58.97
NVDQ for participant 4 at Baseline 54.88
NVDQ for participant 1 at 12 mos 52.38
NVDQ for participant 2 at 12 mos 44.74
NVDQ for participant 3 at 12 mos 54.00
NVDQ for participant 4 at 12 mos 45.45
2.Secondary Outcome
Title REM Percentage at Baseline, 6, 12 and 18 Months
Hide Description REM percentage is the percentage of sleep spent in REM
Time Frame Baseline, 6, 12 and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Donepezil
Hide Arm/Group Description:
Donepezil
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of sleep
REM percentage, participant 1, Baseline 17.2
REM percentage, participant 2, Baseline 18.6
REM percentage, participant 3, Baseline 19.9
REM percentage, participant 4, Baseline 12.1
REM percentage, participant 1, 6 mos 27.5
REM percentage, participant 2, 6 mos 18.8
REM percentage, participant 3, 6 mos 9.7
REM percentage, participant 4, 6 mos 18.9
REM percentage, participant 1, 12 mos 18.2
REM percentage, participant 2, 12 mos 10.1
REM percentage, participant 3, 12 mos 27.5
REM percentage, participant 4, 12 mos 8.5
REM percentage, participant 1, 18 mos 27.8
REM percentage, participant 2, 18 mos 6
REM percentage, participant 3, 18 mos 19.8
REM percentage, participant 4, 18 mos 11.6
3.Other Pre-specified Outcome
Title An Exploratory Analysis Will Investigate Whether Normalization of REM Parameters Also Improves Other Measurements of Sleep Quality in Children With Autism.
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Mullen Scales at 18 Months
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Autism Diagnostic Observation Schedule (ADOS) at 6, 12 and 18 Months
Hide Description [Not Specified]
Time Frame 6, 12 and 18 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Vineland Parent Questionnaire at 3, 6, 12 and 18 Months
Hide Description [Not Specified]
Time Frame 3, 6, 12 and 18 months
Outcome Measure Data Not Reported
Time Frame Baseline to 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label Donepezil
Hide Arm/Group Description Donepezil
All-Cause Mortality
Open-Label Donepezil
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label Donepezil
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-Label Donepezil
Affected / at Risk (%)
Total   0/4 (0.00%) 
Study terminated due to lack of recruitment. No conclusions regarding the use of donepezil can be drawn from small sample size data collection.
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: Ashura W Buckley
Organization: National Institute of Mental Health (NIMH)
Phone: (301) 496-5190
EMail: shu.buckley@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT01887132     History of Changes
Other Study ID Numbers: 130164
13-M-0164
First Submitted: June 22, 2013
First Posted: June 26, 2013
Results First Submitted: August 14, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017