Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Intracerebral Hemorrhage Clinical Trial

— BEACH  

Official title:

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020535
• Other study ID #: IRB00295926
• Secondary ID: 1R01AG069930-01R
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Daniel Hanley
• Phone: (410) 361-7999
• Email: dhanley[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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).

This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.

MW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2026
• Est. primary completion date: December 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• MW189
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)

Other:
• Saline
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)

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	New York University Grossman School of Medicine	Brooklyn	New York
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas Houston	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	University of Texas San Antonio	San Antonio	Texas
United States	Cleveland Clinic Florida	Stuart	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA), University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the proportion of all cause-morality between arms	Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.	7 days post-randomization