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Completed

NCT Number: NCT03168581

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

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

Completed

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CN-105

Drug

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AegisCN LLC

Industry

Collaborators

  • Duke Clinical Research Institute
  • PharPoint Research, Inc.

Registry information

Official study title

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

Acronym: CATCH

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 30, 2017
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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