Clinical trial NCT04091945: A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Lumosa Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with AIS.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of subject have symptomatic intracranial hemorrhage (sICH) of a single dose LT3001 drug product in subjects with AIS.
timeFrame: Within 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Edison
country: United States
facility: JFK Neuroscience Institute, JFK Medical Center
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University - Wexner Medical Center
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurologic Research
state: Tennessee
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: