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This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant human tissue kallikrein | Experimental | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
|
| Placebo | Placebo Comparator | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human tissue kallikrein | Drug | Recombinant human tissue kallikrein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 | Assessed by total number and severity of all treatment-related adverse events. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to Day 90 of NIH Stroke Scale. | Assessed by a reduction in points from baseline. | 90 Days |
| Changes from baseline to Day 90 of Barthel Index. | Assessed by an increase in points from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Campbell | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lismore Base Hospital | Lismore | New South Wales | Australia | |||
| Liverpool Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41195862 | Derived | Campbell BC, Kasner SE, Lista AD, Volpi JJ, Kleinig TJ, Cordato D, Dewey HM, Choi PM, Garcia-Esperon C, Sahathevan R, Wijeratne T, Wong AA, Ghia D, Cloud GC, Giuffre M, Bath PM; ReMEDy1 Investigators. Safety and tolerability of Rinvecalinase Alfa (DM199) for acute ischemic stroke (ReMEDy1). Int J Stroke. 2025 Nov 6:17474930251396480. doi: 10.1177/17474930251396480. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 |
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| Placebo | Other | Placebo Comparator: Phosphate buffered saline |
|
| 90 Days |
| Changes from baseline to Day 90 of Modified Rankin Scale. | Assessed by a reduction in points from baseline. | 90 Days |
| Liverpool |
| New South Wales |
| Australia |
| John Hunter Hospital | New Lambton Heights | New South Wales | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | Australia |
| Princess Alexandria Hospital | Woolloongabba | Queensland | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Sunshine Hospital | St Albans | Victoria | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | Australia |
| Royal Adelaide Hospital | Adelaide | Australia |
| Ballarat Health Services | Ballarat | Australia |
| Box Hill Hospital | Box Hill | Australia |
| Sep 20, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000726994 | DM199 |
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