Trial | NCT03885258  Report issue

Title

Melatonin Replacement Therapy in Pinealectomized Patients
Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    5
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.
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 Started
May 02
2017
Primary Completion
Nov 30
2018
Study Completion
Feb 28
2019
Last Update
Mar 21
2019

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.

Melatonin Replacement Therapy Experimental

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.

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
No Results Posted