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

Acute Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290560
• Other study ID #: DM199-2017-001
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: February 2020
• Source: DiaMedica Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (a1-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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Recombinant human tissue kallikrein
Recombinant human tissue kallikrein

Other:
• Placebo
Placebo Comparator: Phosphate buffered saline

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Ballarat Health Services	Ballarat
Australia	Box Hill Hospital	Box Hill
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Lismore Base Hospital	Lismore	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Princess Alexandria Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
DiaMedica Therapeutics Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Changes from baseline to Day 90 of NIH Stroke Scale.	Assessed by a reduction in points from baseline.	90 Days
Secondary	Changes from baseline to Day 90 of Barthel Index.	Assessed by an increase in points from baseline.	90 Days
Secondary	Changes from baseline to Day 90 of Modified Rankin Scale.	Assessed by a reduction in points from baseline.	90 Days