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New drug aims to tame brain swelling after bleeding stroke

NCT ID NCT05020535

Disease control Sponsor: Johns Hopkins University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called MW189 in 120 adults who have had a brain bleed (intracerebral hemorrhage). The goal is to see if the drug is safe and can reduce brain swelling. Participants receive the drug within 24 hours of their stroke and are monitored for side effects and survival.

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 120 people

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

Started

Oct 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Confirmed diagnosis of spontaneous, non-traumatic ICH. * 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment) * Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms * Age ≥ 18 years * Able to receive first dose of test article ≤ 24h after onset of ICH symptoms * NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization * Controlled blood pressure (systolic BP \< 180 mm Hg) at randomization. * Premorbid magnetic resonance spectroscopy (mRS) of 0-2 * Has adequate venous access * No planned surgical intervention except EVD * Written informed consent from the patient or legally authorized representative (LAR) Exclusion Criteria: * Unstable hematoma defined as \> 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms. * Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed). * Uncontrolled temp \>38.5˚C at enrollment. * Signs of intracranial infection or emergence of a systemic infection * Is pregnant or lactating * Signs of liver and kidney chronic disease (i.e. creatinine \>2, bilirubin \> 3, receiving dialysis) * Non-reversible bleeding diathesis * Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days. * Anticipated withdrawal of life-sustaining therapies within the first week after admission. * In the opinion of the investigator, patient has any contraindication to the planned study assessments. * In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study. * Concomitant enrollment in another acute interventional study

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Conditions

The condition(s) this trial relates to.

brain edema intracerebral hemorrhage Neuroinflammatory Diseases

As listed by the trial registrant

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

Intracerebral hemorrhage

Contacts and locations

Locations

  • Cleveland Clinic Florida

    Stuart, Florida, 34994, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • New York University Grossman School of Medicine

    Brooklyn, New York, 11220, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Texas Houston

    Houston, Texas, 77030, United States

  • University of Texas San Antonio

    San Antonio, Texas, 78229, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511, United States

More trials for these conditions

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