Trial Outcomes & Findings for Young Blind Child Melatonin Treatment Study (NCT NCT00688935)

NCT ID: NCT00688935

Last Updated: 2019-11-27

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

every 2-4 weeks throughout the entire study

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

Participant milestones
Measure
Melatonin
Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy. Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Overall Study
STARTED
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Young Blind Child Melatonin Treatment Study

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: every 2-4 weeks throughout the entire study

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

SECONDARY outcome

Timeframe: 1 12-hour assessment any time during the study

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

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

Phone: 1-877-733-8313

Results disclosure agreements

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