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Completed

NCT Number: NCT03711903

Evaluation of CN-105 in Subject With Acute Supratentorial Intracerebral Hemorrhage

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.

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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

National Neuroscience Institute

Singapore, 308433

About this study

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.

The study is not powered to test any specific hypothesis in regard to safety and will instead use descriptive methods to describe the experience of the study cohort with respect to adverse and serious adverse events (SAEs), as well as the occurrence of several pre-specified events of interest. The secondary objective of this study will be met by comparing the modified Rankin score (mRS) at 30 days between participants treated with CN-105 with placebo controlled participants The mRS at 30 days will be compared between treated and control participants using the Wilcoxon rank sum test. Exploratory analyses include comparison of treated and control participants for radiographic cerebral edema and hematoma volume and expansion and biological markers of inflammation.

Primary: To assess safety of CN-105 administration in primary ICH.

Secondary: To evaluate whether the administration of CN-105 improves 30-day mortality and functional outcomes by comparing participants treated with CN-105 with placebo controlled participants.

Exploratory:

  • To investigate feasibility of Day 0, 1, 2, and 5 non-contrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema
  • 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.Primary:
  • Number and severity of AEs throughout the duration of the study
  • Number and severity of SAEs throughout the duration of the study
  • In-hospital, 30-day, and 90-day mortality
  • Treatment-related mortality
  • In-hospital neurological deterioration, defined as an increase of National Institutes of Health Stroke Scale (NIHSS), > 2 from baseline and/or decrease of > 2 of Glasgow Coma Scale (GCS), persisting more than 24 hours, and unrelated to sedation
  • Incidence of cerebritis, meningitis, ventriculitis
  • Incidence of systemic infection
  • Incidence of hematoma extension Secondary:.
  • 30- and 90-day mRS
  • Need for intracranial hypertension management
  • NIHSS score, Glasgow Coma Scale, Montreal Cognitive Assessment, Stroke Impact Scale-16, and Barthel Index assessment at hospital discharge and 30 days after ICH
  • Discharge disposition

Exploratory:

  • Day 0, 1, 2, 5 non-contrast head CT as a radiographic surrogate to evaluate progression of perihematomal edema
  • Biochemical surrogates of brain injury, including plasma concentrations of S100B, glial fibrillary acidic protein, metalloproteinase-3 and -9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin-6, tumor necrosis factor-α, and vascular endothelial growth factor, assessed daily for 5 days after ICH or until discharge (concentration time area under the curve assessed for each biomarker)

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 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

1Known pregnancy and lactation 2.Has a temperature greater than 38.5°C at Screening. 3.ICH known to result from trauma. 4.Evidence of infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy) severely limiting the recovery potential of the patient in the opinion of the investigator.

5.Evidence of primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, in the opinion of the investigator or evidence of extra-axial (i.e., subarachnoid or subdural) extension of hemorrhage severely limiting the recovery potential of the patient in the opinion of the investigator.

6.Radiographic evidence of underlying tumor. 7.Known unstable mass or active radiographic evidence and symptoms of herniation syndromes severely limiting the recovery potential of the patient in the opinion of the investigator.

8.Known ruptured aneurysm, arteriovenous malformation, or vascular anomaly. 9.Has a platelet count < 100,000/mL. 10.Has an international normalized ratio (INR) > 1.5 or irreversible coagulopathy either due to medical condition or detected before screening.

11.Is taking new oral anticoagulants (NOACS) or low molecular weight heparin at the time of ICH onset 12.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.

14.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.

15.Concomitant enrollment in another interventional study.

Treatment and study plan

Acetyl-Valine-Serine-Arginine-Arginine-Arginine-NH2 (Ac-VSRRR- NH2).

Drug

The study drug, CN-105 is supplied in amber glass vials containing 4 mL of a concentrated 12.5-mg/mL clear-to-slightly-yellow solution.

Other names: CN105

0.9% Sodium-chloride

Drug

normal saline

Primary outcomes

  1. adverse event

    Time frame: 0-12 hours

    any untoward medical occurrence associated with the use of the drug in a participant

  2. adverse event

    Time frame: 24 hour

    untoward medical occurrence associated with the use of the study drug whether considered related or not

  3. adverse event

    Time frame: 48 hour

    untoward medical occurrence associated with the use of the study drug whether considered related or not

  4. adverse event

    Time frame: 72 hour

    untoward medical occurrence associated with the use of the study drug whether considered related or not

  5. adverse event

    Time frame: 96 hour

    untoward medical occurrence associated wtth the use of study drug whether considered related or not

  6. adverse event

    Time frame: 120 hour

    untoward medical occurrence associated wtth the use of study drug whether considered related or not

  7. adverse event

    Time frame: 30 day

    untoward medical occurrence associated with the use of study drug whether considered related or not

  8. adverse event

    Time frame: 90 day

    untoward medical occurrence associated with the use of study drug whether considered related or not

  9. GCS

    Time frame: 0-12 hour

    score as per scale

  10. GCS

    Time frame: 24H

    scored as per scale

  11. GCS

    Time frame: 48 hours

    scored as per scale

  12. GCS

    Time frame: 72 Hour

    scored as per scale

  13. GCS

    Time frame: 96 hour

    scored as per scale

  14. GCS

    Time frame: at 120 hour

    scored as per scale

  15. GCS

    Time frame: at 30 day

    scored as per scale

  16. NIHSS

    Time frame: 0- 12 hour

    scored as per assessment

  17. NIHSS

    Time frame: 120 hour

    scored as per assessment

  18. NIHSS

    Time frame: 24 hour

    scored as per assessment

  19. NIHSS

    Time frame: 48 hour

    scored as per assessment

  20. NIHSS

    Time frame: 72 hour

    scored as per assessment

  21. NIHSS

    Time frame: 96 Hour

    scored as per assessment

  22. NIHSS score

    Time frame: 30 day

    score as per assessment

  23. Serious adverse event

    Time frame: 48 hour

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  24. Serious adverse event

    Time frame: 0-12 hour

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  25. Serious adverse event

    Time frame: 72 hour

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  26. Serious adverse event

    Time frame: 96 hour

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  27. Serious adverse event

    Time frame: at 90 day

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  28. Serious adverse event

    Time frame: at 120 hour

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  29. Serious adverse event

    Time frame: at 30 day

    An AE is considered serious if the investigator believes any of the following outcomes may occur: death, life threatening AE which places participants at immediate risk of death at the time of the event as it occurred, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect ;Requires inpatient hospitalization or prolongation of existing hospitalization with the exception or preplanned (before the study) hospital admissions, planned admissions, hospitalization of less then 24 hours (after discharge from index hospitalization.

  30. systemic infection

    Time frame: 0-12 hour

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  31. systemic infection

    Time frame: 24 hour

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  32. systemic infection

    Time frame: 48 hour

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  33. systemic infection

    Time frame: 72 hour

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  34. systemic infection

    Time frame: 96 hours

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  35. systemic infection

    Time frame: 120 hours

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  36. systemic infection

    Time frame: 30 day

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  37. systemic infection

    Time frame: 90 day

    presence of any infection supported by clinical diagnosis, or any laboratory work up.

  38. Brain CT scan

    Time frame: 0-12 hour

    evaluate hematoma expansion

  39. Brain CT scan

    Time frame: 24 Hour

    evaluate hematoma expansion

  40. presence of CNS infection

    Time frame: 24 hour

    meningitis, cerebritis, ventriculitis

  41. presence of CNS infection

    Time frame: 72 hours

    meningitis, cerebritis, ventriculitis

  42. presence of CNS infection

    Time frame: 0-12 hour

    meningitis, cerebritis, ventriculitis

  43. presence of CNS infection

    Time frame: 48 hours

    meningitis, cerebritis, ventriculitis

  44. presence of CNS infection

    Time frame: 120 hour

    meningitis, cerebritis, ventriculitis

  45. presence of CNS infection

    Time frame: 96 hour

    meningitis, cerebritis, ventriculitis

  46. presence of CNS infection

    Time frame: 30 day

    meningitis, cerebritis, ventriculitis

  47. presence of CNS infection

    Time frame: 90 day

    meningitis, cerebritis, ventriculitis

  48. Mortality

    Time frame: 0-12 hour

    death related or unrelated to the study drug

  49. Mortality

    Time frame: 48 hour

    death related or unrelated to the study drug

  50. Mortality

    Time frame: 72 hour

    death related or unrelated to the study drug

  51. Mortality

    Time frame: 24 hour

    death related or unrelated to the study drug

  52. Mortality

    Time frame: 96 hour

    death related or unrelated to the study drug

  53. Mortality

    Time frame: 120 hour

    death related or unrelated to the study drug

  54. Mortality

    Time frame: 30- day

    occurrence of death related or not related to the use of the study drug

  55. Mortality

    Time frame: 90 -day

    occurrence of death related or not related to the use of the study drug

Secondary outcomes

  1. outcome as assessed by mRS

    Time frame: 120 hour

    MRS scoring

  2. functional outcome as assessed by mRS

    Time frame: 30 Day

    MRS scoring

  3. outcome as assessed by mRS

    Time frame: 90Day

    MRS scoring

  4. cognitive assessment

    Time frame: 120 Hour

    Montreal cognitive assessment

  5. Discharge disposition

    Time frame: day 90

    The place where the patient was discharge -either home, nursing home or rehabilitation care facilities

  6. cognitive assessment

    Time frame: 30 day

    Montreal cognitive assessment

  7. Barthel index

    Time frame: 120 hour

    score as per assessment

  8. Barthel index

    Time frame: 30 day

    score as per assessment

  9. Barthel index

    Time frame: 90 day

    score as per assessment

Other outcomes

  1. biomarkers of brain injury

    Time frame: 0-12 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  2. biomarkers of brain injury

    Time frame: 24 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  3. biomarkers of brain injury

    Time frame: 48 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  4. biomarkers of brain injury

    Time frame: 72 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  5. biomarkers of brain injury

    Time frame: 96 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

  6. biomarkers of brain injury

    Time frame: 120 hour

    plasma concentrations of s100 B, glial fibrillary acidic protein, metalloproteinase -3 and 9, C-reactive protein, D-dimer, brain natriuretic peptide, interleukin -6, tumor necrosis factor, and vascular epithelial growth factor

Sponsors and collaborators

Lead sponsor

National Neuroscience Institute

Other

Collaborators

  • AegisCN LLC
  • Singapore Clinical Research Institute

Registry information

Official study title

A Phase 2, Randomized, Double Blind, Placebo , Controlled Study To Evaluate The Administration of CN-105 In Participants With Acute Supratentorial Intracerebral Hemorrhage

Acronym: S-CATCH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2018
Registry last updated
Dec 1, 2022

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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