Blind Child Melatonin Treatment Study

Status Terminated

Clinical Trial Summary

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.

Clinical Trial Description

We intend to study as many as 26 blind children through up to three melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 3 treatment plans differ only in the start dose. Successfully treated subjects (of one treatment plan) will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects). ;

Study Design

Related Conditions & MeSH terms

Blindness

Clinical Trial Details

NCT number	NCT00691444
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Terminated
Phase	N/A
Start date	September 2002
Completion date	December 2015

View Details

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