Status:
COMPLETED
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
Lead Sponsor:
Lumosa Therapeutics Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 18 to 90 years
- NIHSS of 4 to 30
- Diagnosis of AIS within 24 hours after stroke symptoms onset
Exclusion
- 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
Key Trial Info
Start Date :
January 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04091945
Start Date
January 27 2020
End Date
February 22 2021
Last Update
December 30 2025
Active Locations (10)
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1
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
2
JFK Neuroscience Institute, JFK Medical Center
Edison, New Jersey, United States, 08837
3
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States, 43210
4
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States, 37403