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

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ClinicalTrials.gov Identifier: NCT03290560
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 21, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 20, 2019

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.



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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 for the duration 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 ≤ 5 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 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.

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


Contacts
Contact: Jennifer Johnson 763-260-1597 jjohnson@diamedica.com

Locations
Australia, Australian Capital Territory
Calvary Public Hospital Recruiting
Bruce, Australian Capital Territory, Australia
Contact: Ronak Patel         
Australia, New South Wales
Lismore Base Hospital Recruiting
Lismore, New South Wales, Australia
Contact: Stephen Moore         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia
Contact: Dennis Cordato         
John Hunter Hospital Recruiting
New Lambton Heights, New South Wales, Australia
Contact: Carlos Garcia Esperon         
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia
Contact: Andrew Wong         
Princess Alexandria Hospital Recruiting
Woolloongabba, Queensland, Australia
Contact: Darshan Shah         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Bruce Campbell, MD         
Sunshine Hospital Recruiting
St Albans, Victoria, Australia
Contact: Tissa Wijeratne         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia
Contact: Darshan Ghia         
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Contact: Timothy Kleinig, MD         
Ballarat Health Services Recruiting
Ballarat, Australia
Contact: Ramesh Sahathevan, MD         
Box Hill Hospital Recruiting
Box Hill, Australia
Contact: Helen Dewey, MD         
Sponsors and Collaborators
DiaMedica Therapeutics Inc
Investigators
Principal Investigator: Bruce Campbell Melbourne Health
  Study Documents (Full-Text)

Documents provided by DiaMedica Therapeutics Inc:

Responsible Party: DiaMedica Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03290560     History of Changes
Other Study ID Numbers: DM199-2017-001
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Stroke
Ischemia
Cerebral Infarction
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