Clinical trial NCT03290560: Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: DiaMedica Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.3
timeFrame: 90 Days
Secondary outcomes:
measure: Changes from baseline to Day 90 of NIH Stroke Scale.
timeFrame: 90 Days
measure: Changes from baseline to Day 90 of Barthel Index.
timeFrame: 90 Days
measure: Changes from baseline to Day 90 of Modified Rankin Scale.
timeFrame: 90 Days
Other outcomes:
Locations:
city: Lismore
country: Australia
facility: Lismore Base Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandria Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Ballarat
country: Australia
facility: Ballarat Health Services
city: Box Hill
country: Australia
facility: Box Hill Hospital
Study officials:
affiliation: Melbourne Health
name: Bruce Campbell
role: PRINCIPAL_INVESTIGATOR
References: