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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT04091945

Run by

Lumosa Therapeutics Co., Ltd.

People needed

24

Starts

2020-01-27

Expected to finish

2021-02-22

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• JFK Neuroscience Institute, JFK Medical Center — Edison, New Jersey, United States
• The Ohio State University - Wexner Medical Center — Columbus, Ohio, United States
• Chattanooga Center for Neurologic Research — Chattanooga, Tennessee, United States
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
• Linkou Chang Gung Memorial Hospital — New Taipei City, Taiwan
• Taipei Medical University - Shuang Ho Hospital — New Taipei City, Taiwan
• China Medical University Hospital — Taichung, Taiwan
• Taichung Veterans General Hospital — Taichung, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.