A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
NCT ID: NCT04091945
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2020-01-27
2021-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LT3001 Drug Product
LT3001 Drug Product
Active comparator
Placebo
Placebo
Placebo comparator
Interventions
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LT3001 Drug Product
Active comparator
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
* NIHSS of 4 to 30
* Diagnosis of AIS within 24 hours after stroke symptoms onset
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Lumosa Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Chao AC, Lee TH, Pettigrew LC, Hannawi Y, Huang HY, Chi NF, Chan L, Chen PL, Devlin T. Intravenous Odatroltide for Acute Ischemic Stroke Within 24 Hours of Onset: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Drug Des Devel Ther. 2024 Jun 6;18:2033-2042. doi: 10.2147/DDDT.S460831. eCollection 2024.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LT3001-201
Identifier Type: -
Identifier Source: org_study_id