A Proof of Concept Study to Evaluate CN-105 in ICH Patients
Status:
Completed
Trial end date:
2020-01-25
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 2
Details
Lead Sponsor:
AegisCN LLC
Collaborators:
Duke Clinical Research Institute PharPoint Research, Inc.