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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887132
First Posted: June 26, 2013
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Results First Submitted: August 14, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 participants signed consent. Only 4 started the study.

Reporting Groups
  Description
Open-Label Donepezil Donepezil

Participant Flow:   Overall Study
    Open-Label Donepezil
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open-Label Donepezil Donepezil

Baseline Measures
   Open-Label Donepezil 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      4 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age [1] 
[Units: Years]
Mean (Full Range)
 3.2 
 (2.1 to 3.9) 
[1] Mean age of the participants at screening.
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      4 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      4 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nonverbal Developmental Quotient (NVDQ)   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   REM Percentage at Baseline, 6, 12 and 18 Months   [ Time Frame: Baseline, 6, 12 and 18 months ]

3.  Other Pre-specified:   An Exploratory Analysis Will Investigate Whether Normalization of REM Parameters Also Improves Other Measurements of Sleep Quality in Children With Autism.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   Mullen Scales at 18 Months   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Autism Diagnostic Observation Schedule (ADOS) at 6, 12 and 18 Months   [ Time Frame: 6, 12 and 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Vineland Parent Questionnaire at 3, 6, 12 and 18 Months   [ Time Frame: 3, 6, 12 and 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated due to lack of recruitment. No conclusions regarding the use of donepezil can be drawn from small sample size data collection.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ashura W Buckley
Organization: National Institute of Mental Health (NIMH)
phone: (301) 496-5190
e-mail: shu.buckley@nih.gov


Publications:

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