Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
NCT ID: NCT03290560
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2018-01-19
2020-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Recombinant human tissue kallikrein
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Recombinant human tissue kallikrein
Recombinant human tissue kallikrein
Placebo
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Placebo
Placebo Comparator: Phosphate buffered saline
Interventions
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Recombinant human tissue kallikrein
Recombinant human tissue kallikrein
Placebo
Placebo Comparator: Phosphate buffered saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment.
3. Subject has NIH stroke score (NIHSS) ≥ 6 and ≤ 25.
4. Subject or legally authorized representative is willing and able to sign written informed consent.
Exclusion Criteria
2. Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
3. Subjects with current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least six months have elapsed since the procedure.
4. Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment.
5. Subject has clinical or laboratory evidence of an active infection at the time of enrollment.
6. Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
8. Subject is pregnant or nursing.
9. Subject is male or female of childbearing potential, is participating in heterosexual sexual activity that could lead to pregnancy, and is unable or unwilling to practice medically effective contraception during the study.
10. Subject is participating in any other investigational device or other drug study ≤ 4 weeks or 5 half-lives of the investigational product, whichever is longer.
11. Subject does not have sufficient venous access for infusion of study treatment or blood sampling.
12. In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study.
13. Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
14. Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
15. Pre-stroke Modified Rankin Scale ≥4
18 Years
ALL
No
Sponsors
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DiaMedica Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Campbell
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health
Locations
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Lismore Base Hospital
Lismore, New South Wales, Australia
Liverpool Hospital
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, Australia
Royal Melbourne Hospital
Parkville, Victoria, 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DM199-2017-001
Identifier Type: -
Identifier Source: org_study_id
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