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Trial record 1 of 4 for:    donepezil and autism
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The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Swedo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00695136
First received: June 10, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
Results First Received: April 22, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Autism
Cognition Disorder
Interventions: Drug: Donepezil hydrochloride
Behavioral: Increase REM sleep percentage

  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
Children were screened with polysomnography and 8 of 16 subjects were found to have low REM sleep% and were eligible to continue with the study. One of the 8 elected not to participate in the dose-finding drug administration.

Reporting Groups
  Description
Open Label Single Arm

The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.

Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study.

Participant Flow:   Overall Study
    Open Label Single Arm  
STARTED     7 [1]
COMPLETED     5  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
unrelated adverse event                 1  
[1] 7



  Baseline Characteristics
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Reporting Groups
  Description
Open Label Single Arm

Single group study of Donepezil

Increase REM sleep percentage :

Donepezil hydrochloride :

Baseline Measures
    Open Label Single Arm  
Number of Participants  
[units: participants]
 		  5  
Age  
[units: participants]
 		 
<=18 years     5  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  5.08  ± 1.62  
Gender  
[units: participants]
 		 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 		 
United States     5  



  Outcome Measures

1.  Primary:   Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.   [ Time Frame: 1 month (from baseline to 1.25 mg dose) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No controls and small number of patients.  


Results Point of Contact:  
Name/Title: Susan E. Swedo, MD
Organization: Pediatrics & Developmental Neuroscience Branch, NIMH
phone: 301-496-5323
e-mail: swedos@mail.nih.gov


Publications:


Responsible Party: Susan Swedo, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00695136     History of Changes
Other Study ID Numbers: 080154, 08-M-0154
Study First Received: June 10, 2008
Results First Received: April 22, 2013
Last Updated: April 22, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration