Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg), Placebo, Thrombectomy.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke AIS. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)
oral suspension, 10 ml twice a day (every 12 hours) for 7 days - Other Placebo
oral suspension,10 ml twice a day (every 12 hours) for 7 days - Procedure Thrombectomy
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Primary outcome measures
- 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 [Time frame: Baseline-hospitalization, 3 and 7 days]
- Change from baseline in the mean functional disability score assessed by modified Rankin Scale (mRS), at 7 days after hospitalization, between the two groups [Time frame: Baseline-hospitalization and 7 days]
Secondary outcome measures (3)
- 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 [Time frame: From baseline to 7 days]
- 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 [Time frame: Baseline-hospitalization, 3 and 7 days]
- Volume of restored penumbra [Time frame: Baseline-hospitalization, 3 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Azienda Sanitaria Universitaria Giuliano Isontina — Trieste
Identifiers
NCT: NCT06777680 · PEALUT - STROKE