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Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

ConditionAcute Ischemic Stroke AIS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorOspedali Riuniti Trieste

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)

    Dietary supplement

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

  • Placebo

    Other intervention

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

  • Thrombectomy

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment groupActive comparator 2 interventions
Group B: Control groupPlacebo comparator 2 interventions

Trial outcomes

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

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

Time frame
Baseline-hospitalization, 3 and 7 days
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

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

Time frame
Baseline-hospitalization and 7 days

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

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

Time frame
Baseline-hospitalization, 3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ospedali Riuniti Trieste

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: