Cerebroprotective Effect of Melatonin in Stroke

NCT05857046 | Recruiting Phase 3 DMC

• 1 other identifier: HGZ83 Morelia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute Ischemic; Strokes Thrombotic

Keywords

Melatonin; Cerebroprotective

Outcome Measures

Primary Outcomes (1)

• Change in functional outcome and mortality

  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 Outcomes (5)

• Change in infarct volume

  3 months

• Change in inflammatory biomarkers

  7 days

• Change in antiapoptotic biomarkers

  7 days

• Change in antioxidant biomarkers

  3 months

• Change endothelial damage

  3 months

Study Arms (2)

Melatonin group

ACTIVE COMPARATOR

Melatonin group will receive prolonged released melatonin tablet 10mg for 7 days, then 10 mg for 83 days.

Drug: Melatonin 10 MG; Other: Placebo

Placebo group

PLACEBO COMPARATOR

Placebo group will receive placebo tablet for 7 days, then for 83 days.

Drug: Melatonin 10 MG; Other: Placebo

Interventions

Melatonin 10 MG DRUG

Patients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days

Also known as: Cronocaps

Melatonin group; Placebo group

Placebo OTHER

Patients received placebo every 12 hours for 7 days and then every 24 hours for 83 days

Melatonin group; Placebo group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator
• Universidad Michoacana de San Nicolás de Hidalgo: collaborator
• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: collaborator

Study Sites (1)

Georgina Ortiz-Martínez

Morelia, Michoacán, 58290, Mexico

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Thrombotic Stroke

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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

• Georgina Ortiz-Martínez, MC

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgina Ortiz Martínez

CONTACT

443120510; gortizm001@gmail.com

Comisión de etica

CONTACT

+52 5556276900; comiteeticainv.imss@gmailo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The placebo and melatonin group will be assigned a sequentially numbered envelope that will be delivered to the patient. It will contain their medication, which was previously randomized by someone not involved in the study. Therefore, neither the researcher, the doctor, nor the patient will know which group they belong to. It is important to mention that the placebo tablets contain lactose and will have no effect on the patient's body.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A phase IIIb clinical trial, randomized double-blind, parallel

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 12, 2023
• Study Start: March 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: July 14, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)