Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

Last updated: January 10, 2025
Sponsor: Ospedali Riuniti Trieste
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Blood Clots

Stroke

Cerebral Ischemia

Treatment

Placebo

co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)

Thrombectomy

Clinical Study ID

NCT06777680
PEALUT - STROKE
  • Ages > 60
  • All Genders

Study 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

Inclusion Criteria:

  • age ≥ 60 years

  • both genders

  • first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CTand CTP, eligible for mechanical thrombectomy according to national guidelines

  • NIHSS > 6

  • compliant patients

  • signed informed consent

Exclusion

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, depressivesyndrome)

  • 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

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste,
    Italy

    Site Not Available

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