Trial Outcomes & Findings for Melatonin Studies of Totally Blind Children (NCT NCT00795236)

NCT ID: NCT00795236

Last Updated: 2019-11-27

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: Approximately 1 year
• Results posted on: 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	Melatonin Subjects with free-running rhythms will take melatonin. Melatonin : One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.	Observational Observe to determine free-running versus entrained status.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin Studies of Totally Blind Children

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Approximately 1 year

Population: 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

PRIMARY outcome

Timeframe: Approximately 1 year

Population: 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

PRIMARY outcome

Timeframe: Approximately 1 year

Population: 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

Melatonin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alfred Lewy

Oregon Health & Science University

Phone: (503) 494-7746

Email: lewy@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place