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Small Molecule

MW189 for Brain Bleed (BEACH Trial)

Phase 2

Recruiting

Led By Linda J. Hanley

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to receive first dose of test article within 24h after onset of ICH symptoms

Controlled blood pressure (systolic BP < 180 mm Hg) at randomization

Must not have

Signs of liver and kidney chronic disease (i.e. creatinine >2, bilirubin > 3, receiving dialysis)

Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days post-randomization

Summary

This trial will study if a new medication is safe and tolerated in patients with a brain bleed.

Who is the study for?

This trial is for adults with a confirmed diagnosis of spontaneous, non-traumatic brain bleeding (ICH) who can start treatment within 24 hours after symptoms begin. They must have a certain level of consciousness and stable blood pressure, not be pregnant or lactating, and cannot have severe liver or kidney issues or infections.

What is being tested?

The BEACH study is testing the safety of MW189 compared to saline in patients with brain hemorrhage. It's a phase 2a pilot study where participants are randomly chosen to receive either MW189 or saline to see how well they tolerate it.

What are the potential side effects?

While specific side effects for MW189 aren't listed, common risks may include reactions at the injection site, potential allergic responses, and general discomfort. The trial aims to assess these side effects thoroughly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can start the trial treatment within 24 hours after my stroke symptoms began.

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My blood pressure is under 180 mm Hg.

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I have been diagnosed with a brain bleed that wasn't caused by an injury.

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I am 18 years old or older.

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I am not scheduled for any surgery except for an external ventricular drain (EVD).

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My brain bleed is between 10 and 60 mL in volume, confirmed by CT scans.

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I can have needles inserted without difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe liver or kidney disease.

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I am expected to undergo brain surgery, which may include a less invasive method or use of Alteplase.

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I do not have any signs of brain or systemic infection.

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I do not have a bleeding disorder that cannot be corrected.

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My recent brain scans show a significant increase in bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the proportion of all cause-morality between arms

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

Group II: ControlPlacebo Group1 Intervention

Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

0 / 12Eligibility criteria met