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Melatonin Replacement Therapy in Pinealectomized Patients

NCT03885258 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-03-21

No results posted yet for this study

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.

Conditions

  • Pineal Tumor

Interventions

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2018-11-30
Completion
2019-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885258 on ClinicalTrials.gov