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Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke (REMEDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290560
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
DiaMedica Therapeutics Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Recombinant human tissue kallikrein Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Multi-Center Evaluation to Assess the Safety and Tolerability of DM199 Administered Intravenously and Subcutaneously in Subjects With Acute Ischemic Stroke
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Arm Intervention/treatment
Experimental: 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.
Drug: Recombinant human tissue kallikrein
Recombinant human tissue kallikrein
Other Name: DM199

Placebo Comparator: Placebo
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Other: Placebo
Placebo Comparator: Phosphate buffered saline




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 [ Time Frame: 90 Days ]
    Assessed by total number and severity of all treatment-related adverse events.


Secondary Outcome Measures :
  1. Changes from baseline to Day 90 of NIH Stroke Scale. [ Time Frame: 90 Days ]
    Assessed by a reduction in points from baseline.

  2. Changes from baseline to Day 90 of Barthel Index. [ Time Frame: 90 Days ]
    Assessed by an increase in points from baseline.

  3. Changes from baseline to Day 90 of Modified Rankin Scale. [ Time Frame: 90 Days ]
    Assessed by a reduction in points from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is >/= 18 years of age
  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:

  1. Subject is currently prescribed angiotensin-converting-enzyme inhibitors (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment during the active treatment period (+5 days) of the study.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290560


Locations
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Australia, New South Wales
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
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia
Australia, Victoria
Alfred Health
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sunshine Hospital
St Albans, Victoria, Australia
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Australia
Royal Adelaide Hospital
Adelaide, Australia
Ballarat Health Services
Ballarat, Australia
Box Hill Hospital
Box Hill, Australia
Sponsors and Collaborators
DiaMedica Therapeutics Inc
Investigators
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Principal Investigator: Bruce Campbell Melbourne Health
  Study Documents (Full-Text)

Documents provided by DiaMedica Therapeutics Inc:

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Responsible Party: DiaMedica Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03290560    
Other Study ID Numbers: DM199-2017-001
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Kallikreins
Coagulants
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs