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New stroke drug shows promise in early trial

NCT ID NCT05403866

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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