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NCT00506259 · ClinicalTrials.gov registry record · Phase 1
Treatment Strategies for Children With Smith-Magenis Syndrome
A Phase 1 study of Self Injurious Behavior and Sleep Disorders, Circadian Rhythm, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00506259: Completed Phase 1 study of Self Injurious Behavior and Sleep Disorders, Circadian Rhythm, sponsored by National Human Genome Research Institute (NHGRI).
NCT00506259 is a Phase 1 study of Self Injurious Behavior and Sleep Disorders, Circadian Rhythm that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 23 participants, below the 106-participant average among 13 other Self Injurious Behavior trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506259, a Phase 1 study of Self Injurious Behavior and Sleep Disorders, Circadian Rhythm, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns. Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study. Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM. Children with SMS participate in a 2-part study, as follows: Part 1 Inpatient Trial Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following: * Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns. * Complete a behavior assessment survey related to the child s behaviors and sleep patterns. * Obtain frequent body temperature measurements. * Collect several saliva samples over a 24-hour period. NIH admission phase: * Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test per
Conditions Studied
Interventions
- DRUG dTR Melatonin (NIH CC PDS)
- DEVICE Phototherapy (Bright Light)
- DRUG Melatonin CR
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-07-17 |
| Est. Completion | 2018-05-22 |
| Phase | Phase 1 |
What the finished NCT00506259 record still lists
NCT00506259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 106-participant average among 13 other Self Injurious Behavior trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Self Injurious Behavior appearing as the primary indexed condition, and to 3 interventions - of which dTR Melatonin (NIH CC PDS) is the first listed.
NCT00506259 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00506259 about?
NCT00506259 is a clinical study titled "Treatment Strategies for Children With Smith-Magenis Syndrome". This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytim...
What is the current status of trial NCT00506259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-07-17. Estimated completion is 2018-05-22.
What conditions does trial NCT00506259 study?
This clinical trial studies the following conditions: Self Injurious Behavior, Sleep Disorders, Circadian Rhythm, Mental Retardation, Chromosome Deletion, Developmental Delay Disorders.
What interventions are being tested in trial NCT00506259?
The interventions under investigation include: dTR Melatonin (NIH CC PDS) (DRUG), Phototherapy (Bright Light) (DEVICE), Melatonin CR (DRUG).
Who is sponsoring clinical trial NCT00506259?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00506259 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00506259's enrollment target sits among peer trials
23 10th of 13 higher than 4 of 13 other Self Injurious Behavior trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Self Injurious Behavior 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.
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