Melatonin Replacement Therapy in Pinealectomized Patients

Early Phase 1

Completed

• Conditions: Pineal Tumor
• Interventions: Drug: Melatonin Replacement Therapy

• Registration Number: NCT03885258
• Lead Sponsor: University of Sao Paulo

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.

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.

Study Timeline

• Study Start: 2017-05-02
• Primary Completion: 2018-11-30
• Study Completion: 2019-02-28
• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin Replacement Therapy	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

Name	Time	Method
cardiac autonomic function - heart rate variability	9 months	The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil