Trial Outcomes & Findings for Melatonin Levels in Smith Magenis Syndrome (SMS) (NCT NCT00691574)
NCT ID: NCT00691574
Last Updated: 2019-11-27
Results Overview
TERMINATED
NA
5 participants
every 2-4 weeks throughout the entire study
2019-11-27
Participant Flow
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participant milestones
| Measure |
Light Box
Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.
Enviro-light artificial light box: Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA.
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Melatonin
Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.
Melatonin: up to 3 mg, daily, for up to 1 year
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Melatonin Levels in Smith Magenis Syndrome (SMS)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: every 2-4 weeks throughout the entire studyPopulation: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 optional, 12-hour assessment towards the end of the studyPopulation: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 2-4 weeks throughout the entire study along with every Circadian Phase Marker assessmentPopulation: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
Adverse Events
Light Box
Melatonin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alfred Lewy, MD, PhD
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place