Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

Ospedali Riuniti Trieste

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke AIS

Treatments: Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg); Procedure: Thrombectomy; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06777680

PEALUT - STROKE

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

co-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy

Treatment:

Procedure: Thrombectomy

Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)

Control group

Placebo Comparator group

Description:

Placebo oral suspension in add-on to mechanical thrombectomy

Treatment:

Other: Placebo

Procedure: Thrombectomy