Melatonin Replacement Therapy in Pinealectomized Patients

University of Sao Paulo

Status and phase: Completed; Early Phase 1

Conditions: Pineal Tumor

Treatments: Drug: Melatonin Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03885258

30460114.5.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Melatonin Replacement Therapy

Experimental group

Description:

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.

Treatment:

Drug: Melatonin Replacement Therapy