Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
ConditionAcute Ischemic Stroke AIS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorOspedali Riuniti Trieste
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)
- Placebo
- Thrombectomy
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov