Melatonin Replacement Therapy in Pinealectomized Patients

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Melatonin

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