Evaluation of CN-105 in Subject With Acute Supratentorial Intracerebral Hemorrhage
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
Phase 2, randomized, double-blind, placebo controlled study to evaluate the administration of
CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be
evaluated for eligibility within 12 hours of symptom onset. Eligible participants (30 active
participants and 30 control participants) will receive CN-105 or placebo 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 as outlined in Section 7.5. 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 mRS at 90 days after first
dose of study agent.
Phase:
Phase 2
Details
Lead Sponsor:
National Neuroscience Institute
Collaborators:
Aegis CN LLC Aegis CN LLC funding , and Singapore Clinical research institute for study monitoring Singapore Clinical Research Institute