Assessing a new drug for treating brain bleeding
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
This study is testing a new drug called MW189 to see if it can safely help people with brain bleeding by reducing inflammation and swelling in the brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 11 sites (Birmingham, Alabama and 10 other locations) |
| Trial ID | NCT05020535 on ClinicalTrials.gov |
What this trial studies
This phase 2a pilot study evaluates the safety and tolerability of MW01-6-189WH (MW189) in patients with intracerebral hemorrhage (ICH). The study aims to monitor both radiographic and clinical endpoints while exploring biochemical biomarkers to assess the drug's effectiveness in reducing neuroinflammation and cerebral edema. MW189 is designed to suppress harmful inflammatory responses associated with brain injuries, and its impact will be measured in human subjects following promising results in animal models. Participants will receive either MW189 or saline as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of spontaneous, non-traumatic intracerebral hemorrhage.
Not a fit: Patients with unstable hematomas or those requiring immediate surgical intervention are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from intracerebral hemorrhage by reducing inflammation and edema.
How similar studies have performed: While this approach is novel in humans, animal studies have shown promising results in reducing neuroinflammation and improving recovery after brain injuries.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 10 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Cleveland Clinic Florida — Stuart, Florida, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Not_yet_recruiting)
- New York University Grossman School of Medicine — Brooklyn, New York, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- University of Texas Houston — Houston, Texas, United States (Recruiting)
- University of Texas San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Linda Van Eldik — University of Kentucky
- Study coordinator: Daniel Hanley
- Email: dhanley@jhmi.edu
- Phone: (410) 361-7999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.