Trial Outcomes & Findings for Blind Child Melatonin Treatment Study (NCT NCT00691444)
NCT ID: NCT00691444
Last Updated: 2019-11-27
Results Overview
TERMINATED
NA
10 participants
biweekly 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 |
0.5mg Melatonin
Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
Melatonin: Subjects will be given up to 0.5 mg daily.
0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).
|
10mg Melatonin
Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
Melatonin: Subjects will be given up to 10 mg daily.
0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).
|
20mg Melatonin
Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
Melatonin: Subjects will be given up to 20 mg daily.
0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).
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|---|---|---|---|
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Overall Study
STARTED
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0
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0
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0
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Overall Study
COMPLETED
|
0
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0
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0
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Overall Study
NOT COMPLETED
|
0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blind Child Melatonin Treatment Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: biweekly 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 yearPopulation: 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
0.5mg Melatonin
10mg Melatonin
20mg Melatonin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
OHSU Integrity Department
Oregon Health and Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place