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Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (BEACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05020535
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : December 12, 2023
Sponsor:
Collaborators:
University of Kentucky
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: MW189 Other: Saline Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, study staff, analytic staff (to patient identifiers), sponsor staff (only to treatment allocation, unblinded to enable handling and review of data and drug accountability prior to database lock)
Primary Purpose: Treatment
Official Title: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
Actual Study Start Date : October 10, 2022
Estimated Primary Completion Date : December 25, 2025
Estimated Study Completion Date : October 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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)
 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)
Placebo Comparator: Control
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)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Difference in the proportion of all cause-morality between arms [ Time Frame: 7 days post-randomization ]
    Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020535


Contacts
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Contact: Daniel Hanley (410) 361-7999 dhanley@jhmi.edu
Contact: Cailin Brady (443) 927-3970 whisle1@jh.edu

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Elizabeth Liptrap, MD    240-687-5928    elizabethle@uabmc.edu   
Principal Investigator: Elizabeth Liptrap, MD         
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Chitra Venkatasubramanian, MD    650-723-4448    chitrav@stanford.edu   
Principal Investigator: Chitra Venkatasubramanian, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Jessica Magid-Berntein    203-737-1057    jessica.magid-bernstein@yale.edu   
Principal Investigator: Jessica Magid-Berntein, MD         
United States, Florida
Cleveland Clinic Florida Recruiting
Stuart, Florida, United States, 34994
Contact: Marc Babi, MD    772-332-8073    BabiM@CCF.org   
Principal Investigator: Marc Babi, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Kevin Hatton, MD    859-218-0115    kevin.hatton@uky.edu   
Principal Investigator: Kevin Hatton, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Wendy Ziai, MD    410-292-6046    weziai@jhmi.edu   
Contact: Daniel F Hanley, Jr    410-614-6996    dhanley@jhmi.edu   
Principal Investigator: Wendy Ziai, MD         
United States, New Mexico
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Andrew Carlson, MD    505-272-9494    AndrewCarlson@salud.unm.edu   
Principal Investigator: Andrew Carlson, MD         
United States, New York
New York University Grossman School of Medicine Recruiting
Brooklyn, New York, United States, 11220
Contact: Aaron Lord, MD    718-630-8218    Aaron.Lord@nyulangone.org   
Principal Investigator: Aaron Lord, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Mario Zuccarello, MD    513-558-3556    Mario.Zuccarello@uc.edu   
Principal Investigator: Mario Zuccarello, MD         
United States, Texas
University of Texas Houston Recruiting
Houston, Texas, United States, 77030
Contact: Tiffany Chang, MD    713-500-6128    Tiffany.R.Chang@uth.tmc.edu   
Principal Investigator: Tiffany Chang, MD         
University of Texas San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Justin Mascitelli, MD       mascitelli@uthscsa.edu   
Principal Investigator: Justin Mascitelli, MD         
Sponsors and Collaborators
Johns Hopkins University
University of Kentucky
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Linda Van Eldik University of Kentucky
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05020535    
Other Study ID Numbers: IRB00295926
1R01AG069930-01 ( U.S. NIH Grant/Contract )
R01AG069930 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Intracerebral hemorrhage
MW01-6-189WH
MW189
 Radiographic perihematomal edema
Neuroinflammation
Cerebral edema
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases