NCT05020535

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
16mo left

Started Oct 2022

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2022Oct 2027

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

August 19, 2021

Last Update Submit

April 1, 2026

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhageMW01-6-189WHMW189Radiographic perihematomal edemaNeuroinflammationCerebral edema

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Control

PLACEBO COMPARATOR

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

Interventions

MW189DRUG

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)

Experimental
SalineOTHER

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)

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of spontaneous, non-traumatic ICH.
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Cleveland Clinic Florida

Stuart, Florida, 34994, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

New York University Grossman School of Medicine

Brooklyn, New York, 11220, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Texas Houston

Houston, Texas, 77030, United States

Location

University of Texas San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

  • 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.

    PMID: 41040632DERIVED

  • 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.

    PMID: 40236420DERIVED

MeSH Terms

Conditions

Cerebral HemorrhageNeuroinflammatory DiseasesBrain Edema

Interventions

TT-301Sodium Chloride

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInflammation

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Linda Van Eldik

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

October 10, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-04

Locations

US(11)