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Clinical Trial Summary

This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.


Clinical Trial Description

After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03258294
Study type Interventional
Source Samsung Medical Center
Contact
Status Enrolling by invitation
Phase Phase 4
Start date January 13, 2016
Completion date December 30, 2018

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