Clinical trial NCT05020535: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Official title: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral hemorrhage
MW01-6-189WH
MW189
Radiographic perihematomal edema
Neuroinflammation
Cerebral edema
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
name: National Institute on Aging (NIA)
First posted: 2021-08-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 1:1
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Difference in the proportion of all cause-morality between arms
timeFrame: 7 days post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Stuart
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: New York University Grossman School of Medicine
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
Study officials:
affiliation: University of Kentucky
name: Linda Van Eldik
role: PRINCIPAL_INVESTIGATOR
References: