New stroke drug shows promise in early trial
NCT ID NCT05403866
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested a drug called LT3001 in 89 people who had an acute ischemic stroke. Participants received either the drug or a placebo within 24 hours of their stroke. The study found no serious drug-related side effects, suggesting LT3001 is safe. Researchers are now looking at whether it helps patients recover better than standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LT3001 (a drug given by IV infusion to treat stroke)
- What this could lead to
- If successful, LT3001 could offer a new treatment option for acute ischemic stroke, potentially improving recovery when given within 24 hours of symptoms.
- What could go wrong
- This is an early Phase 2 trial with only 89 participants, so results may not apply to all stroke patients. The drug's effectiveness is still unproven, and larger studies are needed.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
89 people
The number who actually took part.
- Started
-
Aug 2022
- Finished
-
May 2025
- Lead sponsor
-
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
-
18 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Subject is aged 18 to 90 years. 2. Subject has an NIHSS of 6 to 25. 3. Subject is able to receive the first IP within 24 hours after stroke symptoms onset. Neuroimaging Inclusion Criteria: 1. Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT). 2. Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL. Exclusion Criteria: 1. Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS. 2. Subject has a pre-stroke disability (mRS ≥2). 3. Subject has large ischemic core volume \>70 mL or ASPECTS ≤5. 4. Subject has symptoms of suspected subarachnoid hemorrhage. 5. Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment. 6. Subject has significant mass effect with midline shift. 7. Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations. 8. Subject has current uncontrolled hypertension despite treatment. 9. Subject has INR \>1.7 or abnormal aPTT or platelet count \<100,000/mm\^3. 10. Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration. 11. Subject has blood glucose concentration \<50 mg/dL or \>400 mg/dL. 12. Subject has moderate or severe hepatic, renal, and/or active infectious disease. 13. Subject is lactating, pregnant, or planning to become pregnant during the study. 14. Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening. 15. Subject has had any major surgery within 90 days before Screening. 16. Subject has had a bleeding event within 21 days before Screening. 17. Subject has puncture of noncompressible vessels within 7 days before Screening. 18. Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer). 19. In the opinion of the Investigator, the subject is not appropriate for the study.
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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.
Contacts and locations
Locations
-
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403, United States
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