Clinical trial NCT06777680: Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
Official title: Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke AIS
Keywords: Stroke
Neuroinflammation
Palmitoylethanolamide
Luteolin
Lead sponsor: Ospedali Riuniti Trieste
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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

Primary outcomes:
measure: 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
timeFrame: Baseline-hospitalization, 3 and 7 days
measure: Change from baseline in the mean functional disability score assessed by modified Rankin Scale (mRS), at 7 days after hospitalization, between the two groups
timeFrame: Baseline-hospitalization and 7 days
Secondary outcomes:
measure: Incidence of death and/or major vascular events (recurrent strokes, myocardial ischemia or peripheral arterial ischemia) from baseline to 7 days after hospitalization, between the two groups
timeFrame: From baseline to 7 days
measure: Change from baseline of inflammatory and brain damage mediators [interleukin- 6 (IL-6), matrix metalloproteinase- 9 (MMP-9) and neurofilament light (NfL)] plasma levels at 3 and 7 days after hospitalization, between the two groups
timeFrame: Baseline-hospitalization, 3 and 7 days
measure: Volume of restored penumbra
timeFrame: Baseline-hospitalization, 3 days
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina
Study officials:
affiliation: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
name: Marcello Naccarato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: