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

Acute Ischemic Stroke Clinical Trial

Official title:

A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091945
• Other study ID #: LT3001-201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 27, 2020
• Est. completion date: March 2021

Study information

• Verified date: September 2020
• Source: Lumosa Therapeutics Co., Ltd.
• Contact: Sabrina Yeh
• Phone: +886 2 26557918
• Email: sabrina_yeh[@]lumosa.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with AIS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• LT3001 Drug Product
Active comparator
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
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
United States	Chattanooga Center for Neurologic Research	Chattanooga	Tennessee
United States	The Ohio State University - Wexner Medical Center	Columbus	Ohio
United States	JFK Neuroscience Institute, JFK Medical Center	Edison	New Jersey
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Lumosa Therapeutics Co., Ltd.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subject have symptomatic intracranial hemorrhage (sICH) of a single dose LT3001 drug product in subjects with AIS.	Compare the the percentage of subject having symptomatic intracranial hemorrhage (sICH) between LT3001 drug product and Placebo.	Within 36 hours