Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
Launched by OSPEDALI RIUNITI TRIESTE · Jan 10, 2025
Trial Information
Current as of July 13, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two medications, Palmitoylethanolamide (PEA) and luteolin, on patients who have experienced an acute ischemic stroke. An acute ischemic stroke happens when blood flow to the brain is blocked, which can cause brain damage and complications even after the blockage is removed. The goal of the study is to see if these treatments can help improve recovery and reduce inflammation in patients undergoing a procedure called mechanical thrombectomy, which is used to restore blood flow.
To be eligible for the trial, participants must be at least 60 years old and have had their first stroke in a specific area of the brain confirmed by imaging tests. They should have a certain level of stroke severity and need to be able to give consent to participate. However, individuals with a history of certain medical conditions, such as previous strokes, neurodegenerative diseases, or severe diabetes, will not be able to take part. If you join the trial, you will receive the study medications and be closely monitored for any effects they may have on your recovery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • age ≥ 60 years
- • both genders
- • first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CT and CTP, eligible for mechanical thrombectomy according to national guidelines
- • NIHSS \> 6
- • compliant patients
- • signed informed consent
- Exclusion Criteria:
- • hemorrhagic stroke
- • previous stroke (TIA, ischemic or hemorrhagic stroke)
- • presence of clinically evident neurodegenerative diseases (Alzheimer's disease, Parkinson's disease)
- • presence of psychiatric comorbidity (schizophrenia, bipolar disorder, depressive syndrome)
- • presence of chronic inflammatory diseases (chronic inflammatory bowel disease, vasculitis etc.)
- • current or previous neoplasia
- • uncontrolled diabetes mellitus (glycemia on admission \>400 mg/dL or \<50 mg/dL)
- • dysphagia, with inability to feed orally
- • inability to provide informed consent
- • pre-existing disability (pre-stroke mRS \>2)
- • allergy or hypersensitivity to the study treatment
About Ospedali Riuniti Trieste
Ospedali Riuniti Trieste is a prominent healthcare institution in Italy, dedicated to advancing medical research and improving patient care through innovative clinical trials. With a focus on multidisciplinary collaboration, the hospital provides a robust infrastructure for conducting high-quality research across various therapeutic areas. Committed to ethical standards and patient safety, Ospedali Riuniti Trieste actively engages in partnerships with academic institutions and industry leaders to foster the development of new treatments and enhance clinical outcomes. Their comprehensive approach ensures the integration of cutting-edge science with compassionate healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Trieste, , Italy
Patients applied
Trial Officials
Marcello Naccarato, MD, PhD
Principal Investigator
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported