NCT03885258

Melatonin Replacement Therapy in Pinealectomized Patients

Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pineal Tumor

Interventions

Type	Name	Description
DRUG	Melatonin Replacement Therapy	Melatonin (Aché Pharmaceutics, Brazil), 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity.

Timeline

• Start date: 2017-05-02
• Primary completion: 2018-11-30
• Completion: 2019-02-28
• First posted: 2019-03-21
• Last updated: 2019-03-21

Locations

1 site across 1 country: Brazil