A Proof of Concept Study to Evaluate CN-105 in ICH Patients

Study Overview
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Brief Summary
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A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants (approximately 60) will receive CN-105 administered intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days). Participants will be monitored daily throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive standard-of-care treatment for the duration of the study. Additional protocol assessments will be required during the Treatment phase. After discharge from the hospital, participants will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after first dose of study agent. Funding Source - FDA OOPD

Official Title
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A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: CN-105


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR). Stated willingness to comply with all study procedures and availability for the duration of the study. Is male or female, age 30 to 80 years, inclusive. Has a confirmed diagnosis of spontaneous supratentorial ICH. Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, such as alteration in level of consciousness, severe headache, nausea, vomiting, seizure, and/or focal neurological deficits, or last-known well time. Has an interpretable and measurable diagnostic CT scan. Has a Glasgow Coma Scale (GCS) score ≥ 5 on presentation Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4. Has systolic BP (SBP) < 200 mm Hg at enrollment. Exclusion Criteria: Is pregnant or lactating. Has a temperature greater than 38.5°C at Screening. Has ICH resulting from trauma. Has infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy). Has primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, or extra-axial (ie, subarachnoid or subdural) extension of hemorrhage. Has radiographic evidence of underlying tumor. Has an unstable mass or evolving intracerebral compartment syndrome. Has a ruptured aneurysm, arteriovenous malformation, or vascular anomaly. Has a platelet count < 100,000/mL. Has an international normalized ratio (INR) < 1.6 or irreversible coagulopathy either due to medical condition or detected before screening. In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-105. In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which, in the opinion of the investigator, unacceptably increases the individual's risk by participating in the study. Concomitant enrollment in another interventional study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CN-105<br>All eligible subjects will receive study drug, CN-105 | Drug: CN-105<br>* Patients with supratentorial intracerebral hemorrhage (ICH) will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants will receive CN-105 administered intravenously (IV) for a 30 -minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CN-105 safety assessment | Number and severity of AEs throughout the duration of the study | 90 days | 
| Mortality | Record In-hospital 30-day mortality | 30 days | 
| Mortality | record 90-day mortality | 90 days | 
| In-hospital neurological deterioration | Increase of National Institutes of Health Stroke Scale (NIHSS), > 2 from baseline, persisting more than 24 hours, and unrelated to sedation. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in 30-day mortality | Compare participants treated with CN-105 with matched controls | 30 days | 
| Improvement in 30-day functional outcomes | Compare participants treated with CN-105 with matched controls | 30 days |