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Intracerebral HemorrhagePhase 2CATCHNCT03168581

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

A Phase 2 study testing CN-105 in people with Intracerebral Hemorrhage, run by AegisCN LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
CN-105
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
5 sitesUnited States
Study dates
28 Aug 2017to 25 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • Duke University Health System

    Durham, North Carolina, 27709

  • A.B. Chandler Medical Center-University of Kentucky

    Lexington, Kentucky, 40536

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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

Being tested
CN-105
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CN-105Drug

    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)

Study groups in NCT03168581
Study groupRoleWhat they receive
CN-105ExperimentalAll eligible subjects will receive study drug, CN-105
Receives: Drug: CN-105

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CN-105 safety assessment

    Number and severity of AEs throughout the duration of the study

    Measured: 90 days

  2. Mortality

    Record In-hospital 30-day mortality

    Measured: 30 days

  3. Mortality

    record 90-day mortality

    Measured: 90 days

  4. 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.

    Measured: 30 days

Secondary outcomes (2)

  1. Improvement in 30-day mortality

    Compare participants treated with CN-105 with matched controls

    Measured: 30 days

  2. Improvement in 30-day functional outcomes

    Compare participants treated with CN-105 with matched controls

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start28 Aug 2017
  3. Primary completion30 Sep 2019
  4. Study completion25 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168581
Sponsor's protocol ID
CATCH
Other IDs
5R01FD005387-02
Acronym
CATCH
Status last verified
Jul 2019
First submitted
2 May 2017
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27990643

  • 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.

    PubMed 27713572

  • 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.

    PubMed 35562205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CN-105 in people with Intracerebral Hemorrhage, run by AegisCN LLC at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CN-105 safety assessment (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168581, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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