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

Phase 2

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: CN-105

• Registration Number: NCT03168581
• Lead Sponsor: AegisCN LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-08-28
• Status Verified: 2019-07
• Primary Completion: 2019-09-30
• Study Completion: 2020-01-25
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. 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).
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Is male or female, age 30 to 80 years, inclusive.
4. Has a confirmed diagnosis of spontaneous supratentorial ICH.
5. 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.
6. Has an interpretable and measurable diagnostic CT scan.
7. Has a Glasgow Coma Scale (GCS) score ≥ 5 on presentation
8. Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4.
9. Has systolic BP (SBP) < 200 mm Hg at enrollment.

Exclusion Criteria

1. Is pregnant or lactating.
2. Has a temperature greater than 38.5°C at Screening.
3. Has ICH resulting from trauma.
4. Has infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy).
5. Has primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, or extra-axial (ie, subarachnoid or subdural) extension of hemorrhage.
6. Has radiographic evidence of underlying tumor.
7. Has an unstable mass or evolving intracerebral compartment syndrome.
8. Has a ruptured aneurysm, arteriovenous malformation, or vascular anomaly.
9. Has a platelet count < 100,000/mL.
10. Has an international normalized ratio (INR) < 1.6 or irreversible coagulopathy either due to medical condition or detected before screening.
11. In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-105.
12. In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI.
13. 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.
14. Concomitant enrollment in another interventional study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CN-105	CN-105	All eligible subjects will receive study drug, CN-105

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in 30-day mortality	30 days	Compare participants treated with CN-105 with matched controls
Improvement in 30-day functional outcomes	30 days	Compare participants treated with CN-105 with matched controls

Trial Locations

Locations (5)

A.B. Chandler Medical Center-University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

University of Virginia Health Systems; 🇺🇸 Charlottesville, Virginia, United States

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States