Can a new infusion drug boost stroke recovery?
NCT ID NCT07754825
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase II trial is testing whether an experimental drug called LT3001 can help people who have had an acute ischemic stroke, which happens when a blood clot blocks blood flow to the brain. The study will include about 300 participants who receive either a high or low dose of LT3001 or a placebo, given by intravenous infusion within 24 hours of stroke onset. The main goal is to see if the drug improves functional recovery, measured by the modified Rankin Scale, compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LT3001, an experimental drug given by intravenous infusion
- What this could lead to
- If effective, LT3001 could offer a new treatment to improve recovery and reduce disability after a stroke.
- What could go wrong
- This is an early-stage trial, so the drug may not work or may have side effects. Results from this phase will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 2. 6 points ≤ NIHSS score ≤ 25 points at randomization; 3. Participants who are able to receive the investigational drug within 24 hours after the onset of stroke; 4. Female Participants of childbearing potential or male Participants whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 5. All participants sign the informed consent form by themselves or their guardians after receiving complete study information. Exclusion Criteria: 1. Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period; 2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points; 3. Neurological signs have improved rapidly and spontaneously at screening; 4. Participants who have used or are using protocol-prohibited medications after the onset; 5. Participants with pre-stroke disability; 6. Imaging evidence of intracranial hemorrhagic diseases, intraparenchymal brain tumor, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or arterial aneurysm requiring treatment; 7. Massive infarction on imaging; 8. Participants who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate; 9. Participants previously diagnosed with concurrent malignant tumors who are currently undergoing anti-tumor treatment or have an expected survival of less than 3 months; 10. Systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg after active antihypertensive therapy; 11. Acute hemorrhage tendency; 12. Blood glucose level \< 50 mg/dL or \> 400 mg/dL; 13. Active visceral hemorrhage; 14. Lactating or pregnant Participants, or women of childbearing potential with positive pregnancy test results; 15. International normalized ratio \> 1.7 or prothrombin time \> 15 s; 16. Participants with a history of serious hypersensitivity; 17. Participants who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening; 18. Participants who underwent any major surgery before screening; 19. Participants with a history of active digestive ulcer before screening; 20. Participants who experienced hemorrhagic disease before screening; 21. Participants who underwent arterial puncture at the site not easy for hemostasis by compression before screening; 22. Presence of active hepatitis, cirrhosis, or severe renal insufficiency; 23. Participants who have participated in another investigational study and used investigational product before screening; 24. Other conditions unsuitable for participation in this study determined by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better