search
Back to results

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

Primary Purpose

Intracerebral Hemorrhage

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MW189
Saline
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral hemorrhage, MW01-6-189WH, MW189, Radiographic perihematomal edema, Neuroinflammation, Cerebral edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama BirminghamRecruiting
  • Stanford University
  • Yale New Haven HospitalRecruiting
  • Cleveland Clinic FloridaRecruiting
  • University of KentuckyRecruiting
  • Johns Hopkins HospitalRecruiting
  • University of New Mexico
  • New York University Grossman School of MedicineRecruiting
  • University of CincinnatiRecruiting
  • University of Texas HoustonRecruiting
  • University of Texas San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2021
Last Updated
October 12, 2023
Sponsor
Johns Hopkins University
Collaborators
University of Kentucky, National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05020535
Brief Title
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Acronym
BEACH
Official Title
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
December 25, 2025 (Anticipated)
Study Completion Date
June 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Kentucky, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral hemorrhage, MW01-6-189WH, MW189, Radiographic perihematomal edema, Neuroinflammation, Cerebral edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel 1:1
Masking
ParticipantCare ProviderInvestigatorOutcomes 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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
MW189
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
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)
Primary Outcome Measure Information:
Title
Difference in the proportion of all cause-morality between arms
Description
Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.
Time Frame
7 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Hanley
Phone
(410) 361-7999
Email
dhanley@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cailin Brady
Phone
(443) 927-3970
Email
whisle1@jh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Van Eldik
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Liptrap, MD
Phone
240-687-5928
Email
elizabethle@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Liptrap, MD
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chitra Venkatasubramanian, MD
Phone
650-723-4448
Email
chitrav@stanford.edu
First Name & Middle Initial & Last Name & Degree
Chitra Venkatasubramanian, MD
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Magid-Berntein
Phone
203-737-1057
Email
jessica.magid-bernstein@yale.edu
First Name & Middle Initial & Last Name & Degree
Jessica Magid-Berntein, MD
Facility Name
Cleveland Clinic Florida
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Babi, MD
Phone
772-332-8073
Email
BabiM@CCF.org
First Name & Middle Initial & Last Name & Degree
Marc Babi, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Hatton, MD
Phone
859-218-0115
Email
kevin.hatton@uky.edu
First Name & Middle Initial & Last Name & Degree
Kevin Hatton, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Ziai, MD
Phone
410-292-6046
Email
weziai@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Daniel F Hanley, Jr
Phone
410-614-6996
Email
dhanley@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Wendy Ziai, MD
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Carlson, MD
Phone
505-272-9494
Email
AndrewCarlson@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Andrew Carlson, MD
Facility Name
New York University Grossman School of Medicine
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Lord, MD
Phone
718-630-8218
Email
Aaron.Lord@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Aaron Lord, MD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Zuccarello, MD
Phone
513-558-3556
Email
Mario.Zuccarello@uc.edu
First Name & Middle Initial & Last Name & Degree
Mario Zuccarello, MD
Facility Name
University of Texas Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Chang, MD
Phone
713-500-6128
Email
Tiffany.R.Chang@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Tiffany Chang, MD
Facility Name
University of Texas San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Mascitelli, MD
Email
mascitelli@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Justin Mascitelli, MD

12. IPD Sharing Statement

Learn more about this trial

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

We'll reach out to this number within 24 hrs