Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
Key facts
- Where
- Trieste, ItalySee the site
Where in Italy
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedali Riuniti Trieste
- Trial code
- NCT06777680
- Record updated
- 16 January 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study
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.
Inclusion: 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: previous stroke (TIA, ischemic or hemorrhagic stroke); current or previous neoplasia; 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.); pre-existing disability (pre-stroke mRS >2); allergy or hypersensitivity to the study treatment; uncontrolled diabetes mellitus (glycemia on admission >400 mg/dL or <50 mg/dL); dysphagia, with inability to feed orally; inability to provide informed consent.