MW189 for Brain Bleed

(BEACH Trial)

Recruiting at 10 trial locations

Overseen By Andrew Carlson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Immunosuppressants, Anti-inflammatories

Disqualifiers: Pregnancy, Liver disease, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 5 days

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have used chronic immunosuppressants or anti-inflammatory drugs (except low-dose aspirin) in the past 7 days.

What makes the drug MW189 unique for treating brain bleeds?

MW189 is a novel drug that targets inflammation in the brain, which is different from traditional treatments that primarily focus on stopping bleeding or repairing blood vessels. This approach may help reduce brain damage and improve recovery after a brain bleed. ^{1 2 3 4 5}

What is the purpose of this trial?

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Research Team

Linda Van Eldik

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

Inclusion Criteria

You had a magnetic resonance spectroscopy score between 0 and 2 before becoming sick.

I am on blood thinners but can stop them if I have symptoms of a brain bleed.

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

Exclusion Criteria

I do not have severe liver or kidney disease.

You are expected to stop life-sustaining treatments within the first week after joining the study.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

MW189 or placebo is administered within 24 hours of symptom onset and every 12 hours for up to 5 days

5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (in-person)

Treatment Details

Interventions

• MW189

Trial Overview 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.

Participant Groups

Group I: Experimental Experimental Treatment 1 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: Control Placebo Group 1 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)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

This case study presents a unique instance of traumatic basal subarachnoid hemorrhage (TBSAH) resulting from cerebellar contusions, which is a rare occurrence, particularly linked to a coup injury from blunt trauma.

The autopsy of a 55-year-old woman revealed massive subarachnoid hemorrhage without any common sources like ruptured aneurysms or vascular malformations, suggesting that cerebellar contusions can be a significant but overlooked cause of TBSAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic basal subarachnoid hemorrhage suspected to have been caused by contrecoup cerebellar contusions: a case report. Sato, T., Tsuboi, K., Nomura, M., et al.[2014]

In a study of 64 patients with traumatic brain stem hemorrhage (TBH) over 5 years, the most common site of hemorrhage was the midline rostral anterior brain stem, which had a surprisingly high survival rate of 71%.

Patients with brain stem hemorrhage associated with transtentorial herniation had a 100% mortality rate, highlighting the severity of this injury pattern compared to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute traumatic midbrain hemorrhage: experimental and clinical observations with CT. Meyer, CA., Mirvis, SE., Wolf, AL., et al.[2016]

In a case study of a 35-year-old woman who suffered traumatic basal subarachnoid hemorrhage (TBSAH) after being punched in the neck, autopsy revealed a massive hemorrhage at the base of the brain with no detectable tears in the vertebro-basilar arteries.

The source of the TBSAH was likely from hemorrhagic cerebellar contusions, indicating that severe neck trauma can lead to significant brain injuries even without direct vascular damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar contusions as a possible cause of traumatic basal subarachnoid hemorrhage: a case report. Chen, JH., Ishikawa, T., Michiue, T., et al.[2010]

In a study of six patients with partial tegmental pontine hemorrhages, common symptoms included miosis, gaze paresis, facial paralysis, and sensory loss, with most patients being hypertensive.

All patients survived with mild long-term effects, particularly oculomotor disturbances, and factors like smaller hemorrhage size, unilateral injury, and lack of coma were associated with better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tegmental pontine hemorrhages: clinical features and prognostic factors. Lancman, M., Norscini, J., Mesropian, H., et al.[2016]

Transplant recipients who experience brain stem death can be safely used as organ donors, as demonstrated by two case reports where liver grafts from such donors resulted in successful transplants with recipients thriving for over 22 months.

Chronic exposure to immunosuppressive drugs does not automatically disqualify transplant patients from being organ donors, suggesting that these organs can still be viable for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of grafts procured from organ transplant recipients. Arvieux, C., Cornforth, B., Gunson, B., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Traumatic basal subarachnoid hemorrhage suspected to have been caused by contrecoup cerebellar contusions: a case report. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Acute traumatic midbrain hemorrhage: experimental and clinical observations with CT. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

Cerebellar contusions as a possible cause of traumatic basal subarachnoid hemorrhage: a case report. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Tegmental pontine hemorrhages: clinical features and prognostic factors. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Use of grafts procured from organ transplant recipients. [2019]