co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg): oral suspension, 10 ml twice a day (every 12 hours) for 7 days
Placebo: oral suspension,10 ml twice a day (every 12 hours) for 7 days
Thrombectomy: Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Study summary
Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement.
Experimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA).
The aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in the mean neurological disability score assessed by National Institutes of Health Stroke Scale (NIHSS), at 3 and 7 days (end of treatment) after hospitalization, between the two groups — Baseline-hospitalization, 3 and 7 days NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficit
Change from baseline in the mean functional disability score assessed by modified Rankin Scale (mRS), at 7 days after hospitalization, between the two groups — Baseline-hospitalization and 7 days mRS consists of 6 grades from 0 to 5, with 0 corresponding to no symptoms and 5 corresponding to severe disability
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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