Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

NCT06777680 | Not Yet Recruiting

• 1 other identifier: PEALUT - STROKE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke AIS

Keywords

Stroke; Neuroinflammation; Palmitoylethanolamide; Luteolin

Outcome Measures

Primary Outcomes (2)

• 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

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

  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

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

  Baseline-hospitalization and 7 days

Secondary Outcomes (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

  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

  Baseline-hospitalization, 3 and 7 days

• Volume of restored penumbra

  Baseline-hospitalization, 3 days

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

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

Control group

PLACEBO COMPARATOR

Placebo oral suspension in add-on to mechanical thrombectomy

Other: Placebo; Procedure: Thrombectomy

Interventions

co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg) DIETARY_SUPPLEMENT

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

Also known as: Glialia® oral suspension, PEALUT® oral suspension

Treatment group

Placebo OTHER

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

Control group

Thrombectomy PROCEDURE

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

Control group; Treatment group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedali Riuniti Trieste: lead

Study Sites (1)

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Italy, Italy

Location

MeSH Terms

Conditions

Stroke; Neuroinflammatory Diseases

Interventions

Luteolin; Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marcello Naccarato, MD, PhD

  Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcello Naccarato, MD, PhD

CONTACT

+39 0403994569; marcello.naccarato@asugi.sanita.fvg.it

Paola Caruso, MD

CONTACT

+39 0403994569; paola.caruso@asugi.sanita.fvg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)