Cerebroprotective Effect of Melatonin in Stroke

March 1, 2024 updated by: Georgina Ortiz-Martínez, Coordinación de Investigación en Salud, Mexico

Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke

Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Melatonin has been proposed as a potential cerebroprotective agent due to its antioxidant, anti-inflammatory, antiapoptotic, and immunomodulatory effects, which oppose the pathophysiological mechanisms of cerebrovascular disease. Melatonin has the potential to improve stroke outcomes and reduce the risk of disability and mortality, making it a promising therapeutic option for stroke patients.

To assess the efficacy of melatonin in patients with acute ischemic CVD, improve clinical outcome, and infarct volume.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

JUSTIFICATION AND OBJECTIVES The objective of this study is to evaluate the protective effect of melatonin on the brain in patients with cerebral infarction. Cerebral infarction is the death of a small part of the brain that can leave moderate or severe disabilities, such as paralysis or death. The current treatment does not attempt to stop all the mechanisms of brain damage that occur with this disease. Melatonin is a substance that probably protects the brain by regulating cell responses to decrease damage and death of brain cells, in addition to decreasing and cushioning the secretion of substances that produce greater damage at the site of the lesion. These effects have been tested in other heart and neurological diseases in children and adults. However, its effectiveness in this disease in humans has not been studied, so it will be evaluated in this study. This medication is already approved for use in humans to improve sleep quality, so its use is safe, and the side effects are mild and may consist of headache, feeling sleepy during the day, and dizziness. These effects are discussed in detail in the risks and discomfort section.

PROCEDURES You will receive the usual treatment and studies for the care of cerebral infarction. In addition, you will be administered melatonin or lactose orally, forming two groups to evaluate the medication's effectiveness. The group will be assigned in a sequentially numbered envelope that I will give you containing your medication, which was previously sorted by someone outside the research, so neither the researcher, nor the doctor, nor you will know which group you are in. It is essential to mention that lactose tablets will have no effect.

The treatment consists of one tablet every 12 hours for 7 days and then one tablet every 24 hours at night until completing 83 days. We will perform a head CT scan upon admission, on day 2, and on day 90. We will also take blood samples for the laboratory (approximately two teaspoons of blood) on days 0 (upon admission), 5, 30, and 90 to measure substances in the blood that may be modified by the medication and confirm its protective effect on the brain. During your hospital stay, your treating physician will evaluate you daily, and we will perform evaluations on days 3 and 5. Once discharged, the patient will attend monthly medical follow-up appointments on days 30, 60, and 90 after the infarction.

The blood samples will be stored for later evaluation, within a period of fewer than 3 years, with the support of the Universidad Michoacana de San Nicolás de Hidalgo and the Centro de Investigación Biomédica de Michoacán. These samples may be used for future research if you authorize them.

If you decide to participate, you will take your medication according to the instructions. We will monitor you during your hospitalization, and you will attend monthly appointments on days 30, 60, and 90. During these appointments, we will perform clinical evaluations, administer questionnaires, conduct a CT scan, take blood samples, and provide melatonin or a placebo. Each appointment will require 60 minutes to perform all the interventions mentioned.

During your illness, you may experience complications specific to cerebral infarction, such as infections, ulcers, or cerebral hemorrhage, which will be addressed, and only in the case of a severe infection, you will be withdrawn from the study.

No travel expenses will be provided for follow-up appointments. BENEFITS AT THE END OF THE STUDY There will be no economic benefits for the patient participating in the study. At the end of the study, we will have gained more knowledge about the effect of melatonin on brain protection for patients with embolism, in order to offer another alternative in treatment that can decrease the complications caused by this disease. The administration of the medication is experimental and we hope that by receiving it, the patient may experience clinical improvement and a decrease in disability, although it is possible that it may not have any effect on the patient.

RISKS AND DISCOMFORT Melatonin has been shown to be a safe medication and is authorized for use in children and adults for the treatment of insomnia and disorders caused by changes in time zone due to travel or working night shifts. This study will evaluate the effectiveness of melatonin in the clinical development of the disease and its complications. By taking this medication, you may experience the following in order of frequency: drowsiness (28%), fatigue (25%), mood changes (16.7%), headache (13.3%), vomiting (13.3%), and hives (5%). If any of these symptoms occur, please contact us to determine the appropriate course of action, whether it be monitoring, treatment, hospitalization, or discontinuation of melatonin. In rare cases, you may experience increased activity, restlessness, decreased temperature, skin rash, insomnia, burping, tearing, fatigue, feeling heavy, nausea, decreased appetite, tiredness, or nighttime urinary incontinence. Again, if any of these symptoms occur, please contact us to determine the appropriate course of action.

The blood sample collection may cause slight pain from the needle and bruising at the puncture site. If these symptoms are not tolerable, please contact us at the phone numbers provided or go to the hospital's emergency department. You will also have an open appointment for emergency services when needed.

RESULTS INFORMATION AND TREATMENT ALTERNATIVES The complete results of this study will be available at the end of 2025 and will be sent to your registered email or phone number. You will be informed about the type of treatment received the results of your studies, as well as the results of the project. If a new treatment that improves your medical condition is discovered during the study, you will be informed immediately.

If any unforeseen events occur directly caused by the research, you will be treated at the IMSS or ISSSTE, depending on the institute you are registered with.

PARTICIPATION OR WITHDRAWAL Your participation is completely voluntary, and you may ask any questions you deem necessary at any time should you have any doubts. You may make the decision that you consider best, without this affecting your relationship with the IMSS or ISSSTE Institute (according to your registration). If you choose to participate in the study, you may leave the study at any time without affecting your care or relationship with the Institute or your doctor, and you may continue with your usual care and treatment.

If you decide to participate, you will have a contact person to stay in communication with the researcher whenever you deem it necessary.

If you choose not to participate, your relationship and care at the institute or with your doctor will not be affected, and you may continue with your usual care and treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico, 58290
        • Recruiting
        • Georgina Ortiz-Martínez
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting to the Emergency Department with acute ischemic CVD
  • Affiliated to the IMSS and ISSSTE,
  • Patients with NIHSS of 5-25 points
  • Patients with an evolution of less than 24 hours,
  • Patients over 18 years of age,
  • Patients with no history of disease that conditions neurological deficit prior to the event

Exclusion Criteria:

  • Patients with cancer, rheumatic diseases, AIDS, immunological disease or conical infection, connective tissue diseases or CVD in the last 3 months,
  • Pregnant patients, with renal or hepatic insufficiency, allergic to iodine
  • Patients who receive thrombolytic
  • Patient who were taking illicit drugs the following medicine: Imipramine, Thioridazine, Cyproterone, Teriflunomide, Abiraterone acetate, deferasirox, obeticholic acid, peginterferon α2b, vemurafenib.

Elimination Criteria:

  • Patients who have an allergic reaction to melatonin
  • Patients who do not keep follow-up appointments
  • Patients who wish to leave the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Melatonin group
Melatonin group will receive prolonged released melatonin tablet 10mg for 7 days, then 10 mg for 83 days.
Drug: Melatonin 10 MG
Patients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days
Other Names:
  • Cronocaps
Other: Placebo
Patients received placebo every 12 hours for 7 days and then every 24 hours for 83 days
Placebo Comparator: Placebo group
Placebo group will receive placebo tablet for 7 days, then for 83 days.
Drug: Melatonin 10 MG
Patients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days
Other Names:
  • Cronocaps
Other: Placebo
Patients received placebo every 12 hours for 7 days and then every 24 hours for 83 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in functional outcome and mortality
Time Frame: 3 months
Is considered improvement, if present a decrease of NIHSS of 10 points on day 30, Or if you have one rating of 0-1 points before the day 7, from the start of symptoms. Is considered deterioration if NIHSS increases more than 4 points the first 5 days of the stroke.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in infarct volume
Time Frame: 3 months
Evaluating the infarct volume size in the placebo and melatonin groups. RR and CI will be calculated. Each one of the parameters will determine effective if we get a RR>1 and a CI, which does not include 1.
3 months
Change in inflammatory biomarkers
Time Frame: 7 days
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the anti-inflammatory (IL-6) effect between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
7 days
Change in antiapoptotic biomarkers
Time Frame: 7 days
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antiapoptotic effect (Casp-3), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
7 days
Change in antioxidant biomarkers
Time Frame: 3 months
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antioxidant effect (SOD), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
3 months
Change endothelial damage
Time Frame: 3 months
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the endothelial damage (FVW), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coordinación de Investigación en Salud, Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Mexicano del Seguro Social
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Universidad Michoacana de San Nicolás de Hidalgo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georgina Ortiz-Martínez, MC, Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HGZ83 Morelia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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