Actively Recruiting
A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)
Led by Lumosa Therapeutics Co., Ltd. · Updated on 2025-06-05
66
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the LT3001 drug product in adults aged 18 to 90 years who have acute ischemic stroke (AIS) and are undergoing a procedure called endovascular thrombectomy (EVT). This Phase IIb, double-blind, randomized, and placebo-controlled study compares LT3001 with a placebo to better understand its impact when added to standard stroke care. The study is sponsored by Lumosa Therapeutics Co., Ltd. Participants receive either the LT3001 drug product or a placebo administered once through an intravenous infusion before EVT. The study includes two parts and ensures participants also receive standard treatments for AIS when appropriate. The timing of treatment is within 24 hours after stroke symptom onset, with detailed brain imaging used to confirm eligibility. During the trial, participants undergo various assessments including brain imaging with MRI or CT scans, neurological exams measuring stroke severity with the NIH Stroke Scale, and monitoring for brain bleeding within 24 hours after dosing. Researchers track safety and clinical changes to evaluate the drug's effects. The total study duration and follow-up details are based on these evaluations, with careful oversight throughout the process.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
- Subject is aged 18 to 90 years, inclusive, at the time of Screening.
- Subject has an NIH Stroke Scale (NIHSS) score of 6 or higher.
- Subject is eligible for endovascular thrombectomy (EVT) within 24 hours after stroke symptom onset and has no severe contrast allergy or absolute contraindication to iodinated contrast.
- Subject can receive the investigational product before EVT and within 24 hours after stroke symptoms start.
- Women of childbearing potential and men with partners of childbearing potential must use at least one highly effective contraception method during the study and for 3 months after dosing.
- Subject can undergo brain perfusion imaging with MRI or CT.
- Subject has symptomatic intracranial occlusion located in the M1 segment of the middle cerebral artery before M2 bifurcation.
- Subject has a Target Mismatch Profile on MRI or CT perfusion with ischemic core volume 70 mL or less and mismatch ratio greater than 1.2 based on RAPID software.
- Alternative neuroimaging criteria apply if standard imaging is inadequate, including specific perfusion and diffusion volume requirements.
You will not qualify if you...
- Subject has received or plans to receive intravenous thrombolytic treatment during the current stroke.
- Subject has been treated with EVT before investigational product administration during the current stroke.
- Subject has pre-stroke disability requiring help with daily living activities (modified Rankin Scale 2 or higher).
- Subject has a large ischemic core volume greater than 70 mL or Alberta Stroke Program Early CT Score (ASPECTS) of 5 or less.
- Subject shows symptoms of suspected subarachnoid hemorrhage or has imaging evidence of acute brain hemorrhage or other brain lesions increasing bleeding risk.
- Subject has significant brain swelling with midline shift.
- Subject has an intracranial stent in the same vascular area that prevents safe use of the neurothrombectomy device.
- Subject has serious medical, neurological, or psychiatric conditions that would affect assessments, such as seizures at stroke onset or dementia.
- Subject has uncontrolled high blood pressure above specified limits at screening.
- Subject has bleeding or coagulation disorders, recent oral anticoagulant use beyond safe limits, low platelet count, low hemoglobin, or abnormal sodium, potassium, or blood glucose levels at screening.
- Subject has severe liver, kidney, or active infectious disease.
- Subject is pregnant, lactating, or planning pregnancy.
- Subject had prior stroke, heart attack, or serious head injury within 90 days.
- Subject had recent major surgery, bleeding event, or puncture of noncompressible vessels within specified timeframes.
- Subject participated in another investigational study with recent investigational product use.
- Investigator judges EVT procedure or study participation unsafe or unsuitable for the subject for any reason.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours after stroke symptom onset
Participants receive a single intravenous infusion of either LT3001 Drug Product or placebo before undergoing endovascular thrombectomy (EVT) for acute ischemic stroke.
1 treatment visit (in-person)
Duration - 24 hours after dosing
Participants are monitored for safety and efficacy outcomes including clinical deterioration and brain imaging within 24 hours after treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
CHI Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
2
Taichung Medical University
Taichung, Taiwan
Actively Recruiting
Research Team
C
Claire Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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