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NCT01887132 · ClinicalTrials.gov registry record · Phase 2
A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01887132: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT01887132 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01887132, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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 studies suggest that less time in REM sleep can be associated with learning and behavior problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase REM sleep in some adults with different disorders. A small study showed that Donepezil can also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can improve communication skills and social interaction in children with ASD. They also want to see if any change in symptoms seems to come from changes in REM sleep. Objectives: \- To see if a medication, Donepezil, can improve the way communication skills and social interaction develop in young children with autism spectrum disorders. Eligibility: \- Children 22 to 44 months of age with ASD. Design: * Participants will be screened with a blood test, heart tests, and a sleep study. During the sleep study, children will sleep in a darkened room for 2 nights with electrodes on their body and a tube under their nose. Parents can sleep in the room with their child. A technician will monitor the room all night. * Participants will take the study medication once a day. * Treatment will be monitored at visits every 3 months. At each visit the participant will take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep studies. * Participation will end after 18 months.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Why NCT01887132 stopped before completion
NCT01887132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01887132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01887132 about?
NCT01887132 is a clinical study titled "A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism". 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 studies suggest that less time in REM sleep can be associated with learning and behavior problems. Do...
What is the current status of trial NCT01887132?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-06. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01887132?
The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG).
Who is sponsoring clinical trial NCT01887132?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01887132's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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