A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Lumosa Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: LT3001 Drug Product; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091945

LT3001-201

Details and patient eligibility

About

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

Enrollment: 24 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 90 years
• NIHSS of 4 to 30
• Diagnosis of AIS within 24 hours after stroke symptoms onset

Exclusion criteria

• Treatement with approved drug during the current AIS
• Pre-stroke disability
• Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
• Suspected subarachnoid hemorrhage
• Seizure
• Uncontrolled hypertension
• INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3
• Blood glucose concentration <50 mg/dL or >400 mg/dL
• Lactating or pregnant subjects or those planning to become pregnant during the study
• Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
• AIS, myocardial infarction, serious head trauma or major surgery within 90 days
• Bleeding event within 21 days
• Puncture of noncompressible vessels within 7 days
• Severe hepatic, renal, and/or infectious disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

LT3001 Drug Product

Active Comparator group

Treatment:

Drug: LT3001 Drug Product

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo