Melatonin Replacement Therapy in Pinealectomized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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

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Pineal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open-label, single-arm, single-center, proof-of-concept study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Melatonin Replacement Therapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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