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Study of LT3001 for Acute Ischemic Stroke

This study is testing a drug called LT3001 for people who have had an acute ischemic stroke (AIS) and are undergoing a procedure called endovascular thrombectomy (EVT). Researchers want to see if LT3001 is safe and effective compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 90 years old, have an NIHSS score (a measure of stroke severity) of 6 or higher, and are eligible for EVT within 24 hours of your stroke symptoms starting. The study will look at whether participants experience symptomatic intracranial hemorrhage (bleeding in the brain) within 24 hours of receiving the drug, and if their condition worsens within 24 hours, as measured by NIHSS and confirmed by MRI. The current recruitment status is unclear.

Study design
This is a Phase II, multicenter, double-blind, randomized, and placebo-controlled study. It plans to enroll 66 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured within 24 hours after the single dosing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05198323

A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT

Active, Not Recruiting
PHASE2Ages 18–90InterventionalTreatment
Lumosa Therapeutics Co., Ltd.
~66 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:LT3001 Drug ProductPlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The occurrence of symptomatic intracranial hemorrhage within 24 hours after the single dosing; clinical deterioration defined as an change in the NIHSS of 4 points or more and confirmed by MRI
Measured over Within 24 hours

Conditions

Acute Ischemic Stroke

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Acute Ischemic Stroke

NCT05198323

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CHI Memorial Hospital

    Chattanooga, Tennesseeno site contact published

  • Taichung Medical University

    Taichung, Taiwanno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

The mismatch ratio is determined by the RAPID software in real time based on the difference between the ischemic core lesion volume and the time-to-maximum (Tmax) \>6s lesion volume. If both a multimodal MRI and CTP are performed before enrollment, the later of the 2 scans is assessed to determine eligibility.

What this trial measures

  • The occurrence of symptomatic intracranial hemorrhage within 24 hours after the single dosing; clinical deterioration defined as an change in the NIHSS of 4 points or more and confirmed by MRIWithin 24 hours