NCT06777680

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ospedali Riuniti Trieste · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg)	oral suspension, 10 ml twice a day (every 12 hours) for 7 days
OTHER	Placebo	oral suspension,10 ml twice a day (every 12 hours) for 7 days
PROCEDURE	Thrombectomy	Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: Italy