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Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke (ReMEDy1)

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Recombinant human tissue kallikrein
Placebo
Sponsored by
DiaMedica Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lismore Base Hospital
  • Liverpool Hospital
  • John Hunter Hospital
  • Royal Brisbane and Women's Hospital
  • Princess Alexandria Hospital
  • Alfred Health
  • Royal Melbourne Hospital
  • Sunshine Hospital
  • Fiona Stanley Hospital
  • Royal Adelaide Hospital
  • Ballarat Health Services
  • Box Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Recombinant human tissue kallikrein

Placebo

Arm Description

A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.

A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes from baseline to Day 90 of NIH Stroke Scale.
Assessed by a reduction in points from baseline.
Changes from baseline to Day 90 of Barthel Index.
Assessed by an increase in points from baseline.
Changes from baseline to Day 90 of Modified Rankin Scale.
Assessed by a reduction in points from baseline.

Full Information

First Posted
September 18, 2017
Last Updated
March 17, 2022
Sponsor
DiaMedica Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03290560
Brief Title
Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
Acronym
ReMEDy1
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DiaMedica Therapeutics Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant human tissue kallikrein
Arm Type
Experimental
Arm Description
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
Intervention Type
Drug
Intervention Name(s)
Recombinant human tissue kallikrein
Other Intervention Name(s)
DM199
Intervention Description
Recombinant human tissue kallikrein
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: Phosphate buffered saline
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
Description
Assessed by total number and severity of all treatment-related adverse events.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Changes from baseline to Day 90 of NIH Stroke Scale.
Description
Assessed by a reduction in points from baseline.
Time Frame
90 Days
Title
Changes from baseline to Day 90 of Barthel Index.
Description
Assessed by an increase in points from baseline.
Time Frame
90 Days
Title
Changes from baseline to Day 90 of Modified Rankin Scale.
Description
Assessed by a reduction in points from baseline.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is >/= 18 years of age Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment. Subject has NIH stroke score (NIHSS) ≥ 6 and ≤ 25. Subject or legally authorized representative is willing and able to sign written informed consent. Exclusion Criteria: 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. Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis. 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. Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment. Subject has clinical or laboratory evidence of an active infection at the time of enrollment. Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency). Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening. Subject is pregnant or nursing. 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. 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. Subject does not have sufficient venous access for infusion of study treatment or blood sampling. In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study. Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits. Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results. Pre-stroke Modified Rankin Scale ≥4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Campbell
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lismore Base Hospital
City
Lismore
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandria Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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