LT3001 for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called LT3001, a potential drug for individuals who have recently experienced an acute ischemic stroke. This type of stroke occurs when a blood clot blocks blood flow to the brain. Participants in the trial are undergoing endovascular thrombectomy, a procedure to remove the clot. The trial aims to determine if LT3001 is safe and effective when administered either once or in multiple doses. Participants may receive either the LT3001 treatment or a placebo, a non-active substance, through an IV. Suitable candidates have had a stroke within the last 24 hours and qualify for the clot-removal procedure. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain blood thinners or have recently taken new oral anticoagulants, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that LT3001 is generally safe for people. Studies have found it well-tolerated, even when administered up to 24 hours after a stroke. Most patients did not experience serious side effects. One study found that LT3001 has a good safety record, causing few problems for patients. Another study confirmed its safety over a longer period. Overall, evidence suggests LT3001 is safe, but further research is ongoing to confirm these results.12345
Why do researchers think this study treatment might be promising for stroke?
Unlike the standard treatments for stroke, which often include clot-busting drugs or surgical interventions, LT3001 offers a new approach by being administered through an intravenous infusion. Researchers are excited about LT3001 because it potentially targets a different aspect of the stroke process, focusing on reducing brain damage during the critical early stages. This unique mechanism could mean faster and more efficient protection of brain cells, potentially leading to better recovery outcomes for stroke patients.
What evidence suggests that LT3001 might be an effective treatment for acute ischemic stroke?
Research has shown that LT3001, which participants in this trial may receive, may help treat sudden strokes caused by blocked blood flow. In earlier studies, almost half of the patients experienced significant improvements in brain function within 30 days. More patients who received LT3001 had excellent recovery compared to those who did not receive it. The treatment proved safe, even when administered up to 24 hours after a stroke. These results suggest that LT3001 could effectively aid recovery after a stroke.23456
Are You a Good Fit for This Trial?
This trial is for individuals who've had a stroke and are eligible for clot removal therapy within 24 hours of symptom onset. They must have a certain severity of stroke, no severe contrast dye allergies, and be able to undergo brain imaging. Women of childbearing age and men with partners of this group must use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LT3001 drug product or placebo via intravenous infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LT3001 Drug Product
- Placebo
Trial Overview
The study tests the safety and effectiveness of LT3001 Drug Product in patients with acute ischemic stroke undergoing endovascular thrombectomy (EVT). Participants will receive either LT3001 or a placebo to see if it improves outcomes after EVT.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Administered by intravenous infusion
Administered by intravenous infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lumosa Therapeutics Co., Ltd.
Lead Sponsor
Citations
LUMOSA THERAPEUTICS ANNOUNCES POSITIVE ...
The results showed that LT3001 maintained a favorable safety profile under an extended 24-hour treatment window and demonstrated clear ...
Intravenous Odatroltide for Acute Ischemic Stroke Within 24 ...
Major neurological improvement (≥4 points NIHSS improvement) from baseline to 30 days was observed in 46.7% (7/14) and 14.3% (1/7) of patients ...
A Study to Evaluate the Safety and Efficacy of LT3001 Drug ...
A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) ...
Lumosa Therapeutics Announces Positive Results from ...
Further, efficacy showed potential for improvements in neurological and functional outcomes based on the majority of LT3001 patients with ...
5.
practicalneurology.com
practicalneurology.com/news/lt3001-increases-likelihood-of-excellent-functional-outcome-after-stroke/2469659/LT3001 Increases Likelihood of Excellent Functional Outcome ...
In the study, more participants treated with LT3001 (21.4%) had an excellent functional outcome (mRS 0-1) compared with participants treated ...
NCT05686642 | Efficacy and Safety of LT3001 on Treating ...
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in ...
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