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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 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.
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.
Interventions
- DRUG Placebo
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01887132
The ClinicalTrials.gov registry entry for NCT01887132 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01887132 reports 0 study locations.
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.
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