Acute Ischemic Stroke AISNCT06777680
Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
A study testing co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg) and Thrombectomy in people with Acute Ischemic Stroke AIS, run by Ospedali Riuniti Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Ischemic Stroke AIS
- What is being tested?
- co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg) and Thrombectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Marcello Naccarato, MD, PhD, +39 0403994569, marcello.naccarato@asugi.sanita.fvg.it
About this study
Official title: Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study
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
- Being tested
- co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg), Placebo, Thrombectomy
- Keywords
- Stroke, Neuroinflammation, Palmitoylethanolamide, Luteolin
- Medical subject headings
- Stroke, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)Dietary supplement
Also called Glialia® oral suspension, PEALUT® oral suspension
oral suspension, 10 ml twice a day (every 12 hours) for 7 days
PlaceboOther
oral suspension,10 ml twice a day (every 12 hours) for 7 days
ThrombectomyProcedure or surgery
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | co-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy Receives: Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg); Procedure: Thrombectomy |
| Control group | Placebo comparator | Placebo oral suspension in add-on to mechanical thrombectomy Receives: Other: Placebo; Procedure: Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline-hospitalization, 3 and 7 days
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
Measured: Baseline-hospitalization, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Naccarato, Ospedali Riuniti Trieste
- Investigators
- Marcello Naccarato, MD, PhD, Principal investigator, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777680
- Sponsor's protocol ID
- PEALUT - STROKE
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT06777680
- Acronym / sponsor ID
- PEALUT - STROKE
- Conditions
- Acute Ischemic Stroke AIS
- Keywords
- Stroke, Neuroinflammation, Palmitoylethanolamide, Luteolin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedali Riuniti TriesteUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg), Procedure: Thrombectomyco-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy |
| Control group | Placebo comparator | Other: Placebo, Procedure: ThrombectomyPlacebo oral suspension in add-on to mechanical thrombectomy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)Also: Glialia® oral suspension, PEALUT® oral suspensionoral suspension, 10 ml twice a day (every 12 hours) for 7 days | Dietary supplement | Treatment group |
| Placebooral suspension,10 ml twice a day (every 12 hours) for 7 days | Other | Control group |
| ThrombectomyEndovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines | Procedure or surgery | Control group, Treatment group |
Primary outcome
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
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
3 secondary outcomes
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
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
Volume of restored penumbra
Time frame: Baseline-hospitalization, 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcello Naccarato, MD, PhD principal investigator
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg) and Thrombectomy in people with Acute Ischemic Stroke AIS, run by Ospedali Riuniti Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcello Naccarato, MD, PhD (+39 0403994569, marcello.naccarato@asugi.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.