Melatonin's protective effects on the brain after a stroke
Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke
This study tests if melatonin can help protect the brain and improve recovery in people who have just had a stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Locations | 1 site (Morelia, Michoacan) |
| Trial ID | NCT05857046 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of melatonin as a cerebroprotective agent in patients with acute ischemic stroke. It aims to determine whether melatonin can improve clinical outcomes and reduce brain damage by regulating cell responses and decreasing harmful substances at the injury site. Participants will receive either melatonin or a placebo in addition to standard stroke treatment, with their progress monitored over time. The study is significant as it explores a novel approach to mitigate the effects of stroke, which currently lacks comprehensive treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 presenting with acute ischemic stroke within 24 hours of symptom onset and with a specific NIHSS score.
Not a fit: Patients with pre-existing neurological deficits, certain medical conditions, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved recovery and reduced disability for stroke patients.
How similar studies have performed: While melatonin has shown promise in other neurological conditions, its effectiveness in treating acute ischemic stroke in humans has not been previously studied, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Morelia, Michoacan
- Georgina Ortiz-Martínez — Morelia, Michoacan, Mexico (Recruiting)
Study contacts
- Principal investigator: Georgina Ortiz-Martínez, MC — Instituto Mexicano del Seguro Social
- Study coordinator: Georgina Ortiz Martínez
- Email: gortizm001@gmail.com
- Phone: 443120510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.