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Trial record 1 of 5 for:    CN-105
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A Proof of Concept Study to Evaluate CN-105 in ICH Patients (CATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168581
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Duke Clinical Research Institute
PharPoint Research, Inc.
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: CN-105 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : January 25, 2020


Arm Intervention/treatment
Experimental: CN-105
All eligible subjects will receive study drug, CN-105
Drug: CN-105
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 Measures :
  1. CN-105 safety assessment [ Time Frame: 90 days ]
    Number and severity of AEs throughout the duration of the study

  2. Mortality [ Time Frame: 30 days ]
    Record In-hospital 30-day mortality

  3. Mortality [ Time Frame: 90 days ]
    record 90-day mortality

  4. In-hospital neurological deterioration [ Time Frame: 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 :
  1. Improvement in 30-day mortality [ Time Frame: 30 days ]
    Compare participants treated with CN-105 with matched controls

  2. Improvement in 30-day functional outcomes [ Time Frame: 30 days ]
    Compare participants treated with CN-105 with matched controls


Other Outcome Measures:
  1. Exploratory CT to evaluate progression of edema [ Time Frame: 30 days ]
    To investigate feasibility of noncontrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema

  2. Exploratory MRI to evaluate progression of edema [ Time Frame: 30 days ]
    To investigate feasibility magnetic resonance imaging (MRI) radiographic surrogate measures to evaluate progression of perihematomal edema

  3. Exploratory neuroinflammatory biomarker assessment to evaluate progression of edema [ Time Frame: 90 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168581


Locations
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United States, Kentucky
A.B. Chandler Medical Center-University of Kentucky
Lexington, Kentucky, United States, 40536
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27709
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
University of Virginia Health Systems
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
AegisCN LLC
Duke Clinical Research Institute
PharPoint Research, Inc.
Investigators
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Principal Investigator: Michael L James, MD Duke University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AegisCN LLC
ClinicalTrials.gov Identifier: NCT03168581    
Other Study ID Numbers: CATCH
5R01FD005387-02 ( U.S. FDA Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases