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

Primary Purpose

Intracerebral Hemorrhage

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CN-105

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

A.B. Chandler Medical Center-University of Kentucky
Duke University Health System
Wake Forest Baptist Health
Medical University of South Carolina
University of Virginia Health Systems

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CN-105

Arm Description

All eligible subjects will receive study drug, CN-105

Outcomes

Primary Outcome Measures

CN-105 safety assessment

Number and severity of AEs throughout the duration of the study

Mortality

Record In-hospital 30-day mortality

Mortality

record 90-day mortality

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.

Secondary Outcome Measures

Improvement in 30-day mortality

Compare participants treated with CN-105 with matched controls

Improvement in 30-day functional outcomes

Compare participants treated with CN-105 with matched controls

Full Information

NCT ID

NCT03168581

First Posted

May 2, 2017

Last Updated

March 9, 2020

Sponsor

AegisCN LLC

Collaborators

Duke Clinical Research Institute, PharPoint Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03168581

Brief Title

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

Acronym

CATCH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

August 28, 2017 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

January 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AegisCN LLC

Collaborators

Duke Clinical Research Institute, PharPoint Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CN-105

Arm Type

Experimental

Arm Description

All eligible subjects will receive study drug, CN-105

Intervention Type

Drug

Intervention Name(s)

CN-105

Intervention Description

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)

Primary Outcome Measure Information:

Title

CN-105 safety assessment

Description

Number and severity of AEs throughout the duration of the study

Time Frame

90 days

Title

Mortality

Description

Record In-hospital 30-day mortality

Time Frame

30 days

Title

Mortality

Description

record 90-day mortality

Time Frame

90 days

Title

In-hospital neurological deterioration

Description

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

Secondary Outcome Measure Information:

Title

Improvement in 30-day mortality

Description

Compare participants treated with CN-105 with matched controls

Time Frame

30 days

Title

Improvement in 30-day functional outcomes

Description

Compare participants treated with CN-105 with matched controls

Time Frame

30 days

Other Pre-specified Outcome Measures:

Title

Exploratory CT to evaluate progression of edema

Description

To investigate feasibility of noncontrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema

Time Frame

30 days

Title

Exploratory MRI to evaluate progression of edema

Description

To investigate feasibility magnetic resonance imaging (MRI) radiographic surrogate measures to evaluate progression of perihematomal edema

Time Frame

30 days

Title

Exploratory neuroinflammatory biomarker assessment to evaluate progression of edema

Description

To investigate feasibility of using serial biochemical markers of neuroinflammation and neuronal injury as a surrogate measure of perihematomal edema and clinical outcome in the setting of spontaneous ICH

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L James, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

A.B. Chandler Medical Center-University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27709

Country

United States

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

University of Virginia Health Systems

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27990643

Citation

Guptill JT, Raja SM, Boakye-Agyeman F, Noveck R, Ramey S, Tu TM, Laskowitz DT. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Escalating Dose and Repeated Doses of CN-105 in Healthy Adult Subjects. J Clin Pharmacol. 2017 Jun;57(6):770-776. doi: 10.1002/jcph.853. Epub 2016 Dec 19.

Results Reference

background

PubMed Identifier

27713572

Citation

Lei B, James ML, Liu J, Zhou G, Venkatraman TN, Lascola CD, Acheson SK, Dubois LG, Laskowitz DT, Wang H. Neuroprotective pentapeptide CN-105 improves functional and histological outcomes in a murine model of intracerebral hemorrhage. Sci Rep. 2016 Oct 7;6:34834. doi: 10.1038/srep34834. Erratum In: Sci Rep. 2017 Jan 05;7:39580. Sci Rep. 2020 Apr 20;10(1):6898.

Results Reference

background

PubMed Identifier

35562205

Citation

Li S, Wangqin R, Meng X, Li H, Wang Y, Wang H, Laskowitz D, Chen X, Wang Y. Tolerability and Pharmacokinetics of Single Escalating and Repeated Doses of CN-105 in Healthy Participants. Clin Ther. 2022 May;44(5):744-754. doi: 10.1016/j.clinthera.2022.03.006. Epub 2022 May 11.

Results Reference

derived

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

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