Melatonin on Clock Genes in Parkinson's Disease

NCT04287543 | Withdrawn Phase 2 DMC

• 1 other identifier: R-2018-785-019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is the second most important neurodegenerative disease that affects about 2% of the population over 60 years of age. About 40% of the Mexican population with PD suffer from sleep disorders, which has been linked to a deregulation of the circadian cycle and therefore of the clock genes. Melatonin is a hormone produced by the pineal gland that regulates the sleep-wake cycle, at pharmacological doses, it is used to decrease sleep disorders; it is suggested that is used could also normalize the levels of the clock genes expression. In rats with PD, a decrease in clock genes levels has been observed, which are restored by administering melatonin. The aim of the study is to evaluate the effect of melatonin on the expression of the PER1 and BMAL1 clock genes in patients with PD during 12 months. A controlled, double-blind, randomized clinical trial will be carried out in patients with a diagnosis of PD. A survey will be applied in order to know the course of the disease and two more tests to rule out some sleep disorder, at the beginning of the study, at the 6th month and at the 12th month. A blood sample (approximately 15 ml) will be taken every 3 months for a year. By random assignment, the participant will be given Melatonin or placebo, which should be taken every day in the morning and evening after meals for one year.

Conditions

Parkinson Disease

Keywords

melatonin; clock genes; BMAL1 gene; PER1 gene

Outcome Measures

Primary Outcomes (1)

• Expression levels of clock genes

  Relative ratio of messenger ribonucleic acid (mRNA) expression of PER1 and BMAL1 genes corresponding to a control (GAPDH) for each sample, measured by an RT-qPCR.

  Change from baseline at third, sixth, ninth and twelfth month

Secondary Outcomes (7)

• SCOPA-Sleep scale

  Change from baseline at third, sixth, ninth and twelfth month

• Epworth scale

  Change from baseline at third, sixth, ninth and twelfth month

• Progression of PD

  Change from baseline at third, sixth, ninth and twelfth month

• Anxiety

  Change from baseline at third, sixth, ninth and twelfth month

• Depression

  Change from baseline at third, sixth, ninth and twelfth month

Study Arms (2)

Melatonin group

EXPERIMENTAL

Patients with PD who will receive 25 mg of melatonin gel at 12 hours a day and half an hour before sleeping for 12 months

Drug: Melatonin

Placebo group

PLACEBO COMPARATOR

Patients with PD who will receive 25 mg of placebo gel at 12 hours a day and half an hour before sleeping for 12 months

Drug: Placebos

Interventions

Melatonin DRUG

25 mg of melatonin gel at noon and 25 mg of melatonin gel 30 minutes before sleeping for 12 months

Melatonin group

Placebos DRUG

25 mg of placebo gel at noon and 25 mg of placebo gel 30 minutes before sleeping for 12 months

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of PD in stages 1-3 of the classification by stages of Hoehn \& Yahr
• Go with a companion to the appointments
• Patients who agree to participate in the study and sign the Informed Consent letter

You may not qualify if:

• Patients with movement disorder other than PD
• Prior pallidotomy, thalamotomy or deep brain stimulation
• Pregnant
• Patients who consume alcohol or coffee
• Patients who consume an antioxidant supplement

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, 44340, Mexico

Location

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Related Links

• INEGI

MeSH Terms

Conditions

Parkinson Disease

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Blanca M. Torres, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of aging laboratory

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: May 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ME (1)