IRB Study Number 00295926
Status Recruiting
Phase Phase 2
Location Tradition Hospital
Institute Neurological Institute
Description
This first-in-patient phase 2a pilot study will assess the safety and tolerability of 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.
To assess the safety and tolerability of MW189 administration through day 7 in patients suffering from non-traumatic intracerebral hemorrhage.
Inclusion Criteria
Patients will be eligible for the study if the following criteria is meet:
- 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 < 160 mm Hg) at randomization.
- Premorbid mRS of 0-2
- Has adequate venous access
- Written informed consent from the patient or legally authorized representative (LAR).
- No planned surgical intervention except EVD
Exclusion Criteria
A subject will not be eligible for inclusion in the study if any of the following criteria are met:
- 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
- Thrombolytic-associated ICH or hemorrhagic conversion of an ischemic stroke, along with other causes of secondary ICH
- Concomitant enrollment in another acute interventional
