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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01FD005387-02 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| PharPoint Research, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CN-105 | Experimental | All eligible subjects will receive study drug, CN-105 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| CN-105 safety assessment | Number and severity of AEs throughout the duration of the study | 90 days |
| Mortality | Record In-hospital 30-day mortality | 30 days |
| Mortality | record 90-day mortality | 90 days |
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in 30-day mortality | Compare participants treated with CN-105 with matched controls | 30 days |
| Improvement in 30-day functional outcomes | Compare participants treated with CN-105 with matched controls |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory CT to evaluate progression of edema | To investigate feasibility of noncontrast head computed tomography (CT) as a radiographic surrogate to evaluate progression of perihematomal edema | 30 days |
| Exploratory MRI to evaluate progression of edema |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L James, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.B. Chandler Medical Center-University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| Duke University Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27990643 | Background | 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. | |
| 27713572 | Background | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 12, 2021 | Feb 2, 2021 | 7 | ||
| Mar 15, 2024 |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000712807 | apolipoprotein E mimetic peptide CN-105 |
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|
| 30 days |
To investigate feasibility magnetic resonance imaging (MRI) radiographic surrogate measures to evaluate progression of perihematomal edema
| 30 days |
| Exploratory neuroinflammatory biomarker assessment to evaluate progression of 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 | 90 days |
| Durham |
| North Carolina |
| 27709 |
| United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27103 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Virginia Health Systems | Charlottesville | Virginia | 22908 | United States |
| 35562205 | Derived | 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. |
| Apr 10, 2024 |
| 8 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |