Status:
TERMINATED
A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism Spectrum Disorders
Eligibility:
All Genders
24-50 years
Phase:
PHASE2
Brief Summary
Background: \- Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of these children spend very little time in the rapid eye movement (REM) stage of sleep. Some s...
Detailed Description
i. Objective The objective of this study is to investigate the efficacy of donepezil to improve the developmental trajectory for core behavioral domains specific to autism, namely reciprocal social i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of an Autism Spectrum Disorder (DSM-IV diagnoses of autistic disorder or Pervasive Developmental Disorder, Not Otherwise Specified).
- Male or Female subjects between the ages of 24 and 50 months.
- Language scores (from the Mullen Scales of Early Learning) that are at least 1.5 SD lower than the mean.
- 5\. Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study.
- 6\. Each subject must be stable for at least 6 weeks on any medication or therapy regimen prior to entry into study and must have no newly (within 6 weeks) recognized or intolerable adverse effects from that medicine or therapy. No subjects will be asked to discontinue any medication in order to qualify for enrollment but subjects taking contraindicated drugs will not qualify for enrollment.
- 7\. Demonstrated REM% two standard deviations or more below the normative values for age for the randomized controlled trial part.
- 8\. English language is primarily spoken at home.
- EXCLUSION CRITERIA:
- Serious, unstable illnesses including gastroenterologic, respiratory, cardiovascular endocrinologic, immunologic, or hematologic disease.
- Renal or hepatic dysfunction that would interfere with excretion or metabolism of donepezil as evidenced by increase above upper limits of normal for BUN/creatinine, or two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT) or gamma glutamate (GGT).
- Documented history of hypersensitivity or intolerance to donepezil or other piperidine derivative.
- Subjects must not be taking any medication known to affect REM sleep (or sleep
- architecture in general) or that is contraindicated for co-administration with donepezil.
- Presence or history of other unstable neurological disorders such as seizure disorders,
- metabolic disorders, narcolepsy or movement disorders.
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01887132
Start Date
June 1 2013
End Date
December 1 2015
Last Update
September 25 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892