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Can a new IV drug boost brain recovery after stroke?

NCT ID NCT07742098

Disease control Sponsor: NeuroTrauma Sciences, LLC Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing an experimental drug called NTS-521, given as an intravenous infusion, to see if it can help people recover better after an acute ischemic stroke. The study will include about 140 adults aged 45 to 80 who have moderate to severe weakness on one side of the body due to a recent stroke. Participants will receive one of three doses of NTS-521 or a placebo, and their safety and recovery will be monitored for 90 days, focusing on improvements in arm and hand movement and overall disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NTS-521 (an experimental drug given intravenously)
What this could lead to
If successful, this could lead to a new treatment that improves motor recovery and reduces disability after a stroke.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Possible risks include side effects from the infusion.

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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

45 to 80 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: * Acute ischemic stroke with moderate to severe hemiparesis * Functional independence in activities of daily living without requiring nursing care before the index stroke. * Consent process by participant or proxy, with reconsent provision. * Age ≥ 45 to ≤ 80 years of age (inclusive) on the date of randomization * Sufficient attention, comprehension, and cooperation to carry out instructions Exclusion Criteria: * Pre-existing motor deficit prior to index stroke * Posterior circulation ischemic stroke * Lacunar stroke * Qualifying brain imaging demonstrating intracranial hemorrhage, malignant middle cerebral artery (MCA) infarct with edema, or bilateral/multifocal infarcts, clinically significant vascular malformation, brain tumor, or other central nervous system (CNS) pathology * Recent major surgery or trauma (\<30 days)

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Conditions

The condition(s) this trial relates to.

ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

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Other studies related to the condition(s) this trial covers.