Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melatonin Replacement Therapy in Pinealectomized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885258
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ovidiu Constantin Baltatu, Anhembi Morumbi University

Brief 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.

Condition or disease Intervention/treatment Phase
Pineal Tumor Drug: Melatonin Replacement Therapy Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label, single-arm, single-center, proof-of-concept study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. cardiac autonomic function - heart rate variability [ Time Frame: 9 months ]
    The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial:
  • children, adolescents and young adults 0 months to 25 years of age;
  • signed written informed consent (patient or his/her parents/legal guardian);
  • willing and able to complete the clinical trial procedures, as described in the protocol
  • no recurring tumor after pinealectomy and subsequent chemotherapy
  • absence of circulating melatonin evaluated by salivary melatonin Elisa assay

Exclusion Criteria:

  • patients with cardiac arrhythmias
  • potentially non-compliant subjects judged by the investigator to be unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885258


Locations
Layout table for location information
Brazil
University of São Paulo
São Paulo, Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ovidiu Constantin Baltatu, Co-PI to PI - José Cipolla-Neto, Anhembi Morumbi University
ClinicalTrials.gov Identifier: NCT03885258    
Other Study ID Numbers: 30460114.5.0000.0068
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ovidiu Constantin Baltatu, Anhembi Morumbi University:
melatonin
pinealectomy
Cardiac Autonomic System
heart rate variability
Additional relevant MeSH terms:
Layout table for MeSH terms
Pinealoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants