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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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)
A.B. Chandler Medical Center-University of Kentucky
Lexington, Kentucky, United States
Duke University Health System
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
CN-105 safety assessment
Number and severity of AEs throughout the duration of the study
Time frame: 90 days
Mortality
Record In-hospital 30-day mortality
Time frame: 30 days
Mortality
record 90-day mortality
Time frame: 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.
Time frame: 30 days
Improvement in 30-day mortality
Compare participants treated with CN-105 with matched controls
Time frame: 30 days
Improvement in 30-day functional outcomes
Compare participants treated with CN-105 with matched controls
Time frame: 30 days
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