Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
NCT ID: NCT06777680
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pre-stroke Cognitive Status and Thrombolytic Therapy
NCT01713491
Platelet Function in Patients With Ischemic Stroke Treated With Anti-thrombotic or Thrombolytic
NCT05415150
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
NCT06211712
Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke
NCT05631847
Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Ischemic Stroke
NCT06863571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
co-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy
co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)
oral suspension, 10 ml twice a day (every 12 hours) for 7 days
Thrombectomy
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Control group
Placebo oral suspension in add-on to mechanical thrombectomy
Placebo
oral suspension,10 ml twice a day (every 12 hours) for 7 days
Thrombectomy
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)
oral suspension, 10 ml twice a day (every 12 hours) for 7 days
Placebo
oral suspension,10 ml twice a day (every 12 hours) for 7 days
Thrombectomy
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ospedali Riuniti Trieste
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marcello Naccarato
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcello Naccarato, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEALUT - STROKE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.