NCT06777680Not yet recruiting
Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke
Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study
Source: ClinicalTrials.gov · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- Jan 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Ospedali Riuniti Trieste
- Diseases
- Stroke
- NCT number
- NCT06777680
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Jan 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous stroke (TIA, ischemic or hemorrhagic stroke)
- current or previous neoplasia
Other illness
- 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.)
- pre-existing disability (pre-stroke mRS \>2)
- allergy or hypersensitivity to the study treatment
Lab values
- uncontrolled diabetes mellitus (glycemia on admission \>400 mg/dL or \<50 mg/dL)
Other
- dysphagia, with inability to feed orally
- inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.