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NCT Number: NCT06777680

Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke AIS Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Inflammation Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)

Dietary Supplement

oral suspension, 10 ml twice a day (every 12 hours) for 7 days

Other names: Glialia® oral suspension, PEALUT® oral suspension

Placebo

Other

oral suspension,10 ml twice a day (every 12 hours) for 7 days

Thrombectomy

Procedure

Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines

Primary outcomes

  1. 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

    NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficit

  2. 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

    mRS consists of 6 grades from 0 to 5, with 0 corresponding to no symptoms and 5 corresponding to severe disability

Secondary outcomes

  1. 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

  2. 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

  3. Volume of restored penumbra

    Time frame: Baseline-hospitalization, 3 days

    Volume of initial penumbra on admission CT perfusion scans not evolved to ischemic lesion on follow-up CT scan at 72 hrs since stroke onset

Study contacts

Contact information is provided by the study sponsor or research team.

Marcello Naccarato, MD, PhD

CONTACT

[email protected]

+39 0403994569

Paola Caruso, MD

CONTACT

[email protected]

+39 0403994569

Sponsors and collaborators

Lead sponsor

Ospedali Riuniti Trieste

Other

Registry information

Official study title

Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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