Table of Contents
- Trial overview
- Study design and treatment groups
- Who can participate
- What the trial measures
- What the results may mean
Trial overview
The available study of Lt3001 is BRIGHT, a Phase 2 trial in people with acute ischemic stroke (AIS).[1] It is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of multiple doses of Lt3001 drug product.[1] The trial is completed and planned to enroll 200 subjects.[1]
Study design and treatment groups
This is an interventional study, which means researchers gave a study treatment and then measured the results.[1] Participants were assigned to either placebo or Lt3001 drug product by chance, which helps make the comparison fair.[1] The Lt3001 group received 0.1 mg/kg by intravenous infusion, meaning the treatment was given through a vein.[1]
Who can participate
The trial data show that the study was for subjects with acute ischemic stroke.[1] No more detailed entry rules are provided in the source data, so the exact age range, timing rules, or other eligibility limits are not listed here.
What the trial measures
The main outcome was the proportion of subjects with adverse events judged to be probably or definitely related to the investigational product within 90 days after the first dose.[1] In simple terms, the researchers wanted to know how many people had unwanted medical problems that seemed linked to the study treatment.[1] The brief study summary also says the trial was done to determine the safety of multiple doses of Lt3001 in subjects with AIS.[1]
What the results may mean
Because this is a Phase 2 trial, the study is mainly about learning more about safety and looking for early signs of benefit rather than proving final effectiveness.[1] The placebo comparison helps researchers judge whether events seen in the Lt3001 group may be different from what happens without the active study treatment.[1] For patients and families, the key point is that this trial focused on people with a serious stroke condition and aimed to understand whether Lt3001 could be studied further in this setting.[1]
