Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
NCT ID: NCT05020535
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2022-10-10
2027-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
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)
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)
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Linda Van Eldik
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Cleveland Clinic Florida
Stuart, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of New Mexico
Albuquerque, New Mexico, 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 Texas San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Liptrap, MD
Role: primary
Chitra Venkatasubramanian, MD
Role: primary
Jessica Magid-Berntein
Role: primary
Marc Babi, MD
Role: primary
Kevin Hatton, MD
Role: primary
Wendy Ziai, MD
Role: primary
Daniel F Hanley, Jr
Role: backup
Andrew Carlson, MD
Role: primary
Aaron Lord, MD
Role: primary
Mario Zuccarello, MD
Role: primary
Tiffany Chang, MD
Role: primary
Justin Mascitelli, MD
Role: primary
References
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Sorensen G, Remillard W, Schlechter M, Kampp M, Whisler Brady C, Kildahl K, Mould A, Ziai W, Lane K, Van Eldik LJ, Distasio A, Lu J, Sansing LH, Hanley DF, Magid-Bernstein J. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. J Clin Transl Sci. 2025 Sep 12;9(1):e215. doi: 10.1017/cts.2025.10152. eCollection 2025.
Sorensen G, Remillard W, Schlechter M, Kampp M, Sansing LH, Brady CW, Kidahl K, Ziai W, Van Eldik L, Distasio A, Lu J, Magid-Bernstein J, Hanley D. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. medRxiv [Preprint]. 2025 Mar 31:2025.03.28.25324776. doi: 10.1101/2025.03.28.25324776.
Other Identifiers
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