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Clinical Trial Summary

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.


Clinical Trial Description

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. The study consists of a screening period, followed by a 3-month melatonin treatment period, and a 6-month washout follow-up period. Adverse events were monitored with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03885258
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Early Phase 1
Start date May 2, 2017
Completion date February 28, 2019

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